Clinical Trials

ASAP-TOO: Assessment of the WATCHMAN^™ Device in Patients Unsuitable for Oral Anticoagulation

Purpose of the research:
To establish the safety and effectiveness of the WATCHMAN Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are not suitable for oral anticoagulation therapy.

Inclusion:

• Documentated AF, CHADS-VASc score of 2 or greater
• Deemed to be unsuitable for oral anticoagulation therapy
• Deemed to suitable for aspirin and clopidogreal therapy post procedure

Exclusion

• Any cardiac procedure within past 30 days
• Prior stroke or TIA within 30 days prior to randomization
• Bleeding event within 14 days prior to randomization
• History if ASD repair

Primary Investigator: James Choi, MD

Who to contact for more info: Jennifer Cruthis 214-820-3319 jennifer.cruthis@bswhealth.org .

Learn more about the study

EXTEND

MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO IN DIABETIC PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 1.

The purpose of the this research study is to find what effects BYDUREON® (EXENATIDE EXTENDED-RELEASE FOR INJECTABLE SUSPENSION)®, a currently FDA approved treatment for type 2 diabetes mellitus, has on heart and kidney function.

Inclusion

• Age =18
• Type 2 diabetes mellitus with hemoglobin A1c 6.6 – 9.9 % with or without the use of insulin

Exclusion

• Allergy to gadolinium or gadodiamide
• Implanted metallic device

Principle Investigator: Peter McCullough, MD

For more information regarding enrollment of this trial, please contact Patrice Perryman at Patrice.Perryman@BSWHealth.org.

QUARK 309

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery (QUARK 309)

A randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney injury following cardiac surgery.

Principle Investigator: Robert F. Hebeler, MD

Type of study: Interventional

Study Synopsis
This randomized, double-blind, placebo-controlled, Phase 3 trial evaluate QPI-1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney injury following cardiac surgery. Patients will be given doses of QPI-1002 or placebo after the completion of cardiovascular surgery. The study will look at the following outcomes metrics: proportion of patients through day 90 who develop major adverse kidney events; proportion of patients developing AKI overall by modified AKIN criteria within five days post-surgery; renal function as estimated by glomerular filtration rate; proportion of subjects who die or initiate dialysis through day 90.

“Acute kidney injury is a fairly frequent occurrence after open heart surgery and can be anywhere from mild to severe with long-term adverse consequences to the patient. The QUARK study examines an agent researchers believe could prevent specific kidney injury following coronary artery bypass. This is a Phase 3 trial with the first two studies producing promising outcomes.” Robert Hebeler, MD, principal investigator.

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria for the reduced ejection fraction study can be found at

https://www.clinicaltrials.gov/ct2/show/NCT03510897?term=QUARK+309&rank=1

Study contact:
For more information regarding enrollment of this trial, please contact Merielle Boatman, MBA, BAAS, Merielle.Boatman@BSWHealth.org, 214.820.2273.

ADAPTABLE

To identify the optimal dose of aspirin for secondary prevention in patients with atherosclerotic cardiovascular disease (ASCVD).

Purpose of the trial: Millions of Americans who have heart disease already take either regular (325 mg) or low-dose (81 mg) aspirin. Even though both doses of aspirin are widely used, no one knows which is better. The goal of ADAPTABLE is to try to find out which dose of aspirin is better for cardiovascular patients.

Inclusion
1. Age =18
2. Known atherosclerotic cardiovascular disease (ASCVD), defined as ANY of the following:
a. Prior myocardial infarction
b. Prior coronary revascularization procedures (either prior PCI or prior CABG)
c. Prior coronary angiography showing =75% stenosis of at least one epicardial coronary vessel
d. History of chronic ischemic heart disease, coronary artery disease, or atherosclerotic cardiovascular disease
3. No known safety concerns or side effects considered to be related to aspirin
4. Not currently treated with an oral anticoagulant—either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban)—and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism.

Exclusion
There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up.

Who to contact for more information:
Sharla Russell Sharla.Russell@BSWHealth.org

CVAD Trial

A registry to assess outcomes using a catheter-mounted, LVAD-like device for PCI.

Primary investigator: Robert Stoler, MD

Who to contact for more information:
Emily Laible, RN, BSN, CCRC, at 214-820-9903

DREAM

A Double-Blind, Randomized, Sham-Procedure-Controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology:
DREAM HF-1.

Primary Investigator: Cara East, MD

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

Learn more about the study

EMPEROR-Preserved

Summary: A Phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Empagliflozin outcome trial in patients with chronic heart failure (EMPEROR-Preserved)

Primary Investigator: Cara East, MD, Peter A. McCullough, MD.

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

EMPEROR-Reduced

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF). Empagliflozin outcome trial in patients with chronic heart failure (EMPEROR-Reduced)

Primary Investigator: Cara East, MD, Peter A. McCullough, MD.

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

GALACTIC-HF

The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF. Inclusion:

• Age/Sex = 18 to 85, female or male
• History of chronic HF
• LVEF 35 percent or less, within 12 months prior to screening
• NYHA class II to IV at most recent screening assessment
• Managed with HF SoC therapies consistent with regional clinical practice guidelines according to investigator judgment of subject’s clinical status
• Current hospitalization with primary reason of HF, OR one of the following events within one year of screening: hospitalization with primary reason of HF; urgent visit to emergency department with primary reason of HF
• Elevated BNP or NT-proBNP

• Currently receiving treatment in another investigational device or drug study, OR less than 30 days since ending treatment on another investigational device or drug study
• Malignancy within five years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage one prostate carcinoma, breast ductal carcinoma in situ
• Known sensitivity to any of the products or components to be administered during testing

GUIDE-HF

GUIDE-HF - Hemodynamic-Guided Management of Heart Failure is a study to evaluate heart failure patients with a recent heart failure hospitalizations and NYHA II or III or IV and the effectiveness of the CardioMEMS HF System device.

Inclusion Criteria:

• Heart Failure Hospitalization within 12 months
• LVEF ≤ 40%: BNP ≥ 250 pg/mL
• LVEF > 40%: BNP ≥ 175 pg/mL

• GFR < 25 mL/min/1.73m2
• Severe Pulmonary Hypertension
• Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent.

HEART-FID

HEART-FID - Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction. The placebo-controlled study assesses the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the six-month change in six minute walk test (6MWT) for patients in heart failure with iron deficiency.

Principal Investigator: Shelley Hall, MD, FACC, FHFSA

For more information about this study, please contact Amanda Doss at Amanda.Doss@BSWHealth.org or 214.865.2419.

INVESTED

The study will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than a standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.

Inclusion:

• Age = 18
• History of hospitalization for myocardial infarction within one year of enrollment OR a history of hospitalization for heart failure within two years of enrollment
• At least one of the following risk factors:
  • Prior MI (if HF the index event above; or a second MI)
  • Prior HF hospitalization (if MI the index event above; or a second HF event)
  • Age = 65 or older
  • LVEF < 40 percent
  • Diabetes mellitus
  • Obesity (BMI = 30 or more)
  • Renal impairment (eGFR = 60 or less)
  • History of ischemic stroke
  • History of peripheral artery disease
  • Current smoker

• Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barre Syndrome within six weeks after influenza vaccine
• Ay non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than nine months
• Receipt of influenza vaccine during current influenza season
• Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.

MOMENTUM 3 CAP Clinical Study

The purpose of this is to evaluate the safety and effectiveness of the HeartMate III LVAS by demonstrating non-inferiority to the HeartMate II LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.

Inclusion Criteria

• Age =18 years and inotrope dependent or on Optimal Medical Management (OMM) for at least 45 out of the last 60 days

Exclusion

• Presence of any risk factors of severe end organ dysfunction

Principle Investigator: Shelley Hall, MD

For more information regarding enrollment of this trial, please contact Horacio Martinez at Horacio.Martinez@BSWHealth.org.

PERSPECTIVE

A multi-center, randomized, double-blind, active-controlled study to evaluate the effects of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction.

Primary Investigator: Cara East, MD

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

Reduce LAP-HF

The purpose of the Reduce LAP-HF study is to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure. The Corvia Medical InterAtrial Shunt Device (IASD®) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard GDMT.

Inclusion Criteria:

• Are you over 40 years of age?
• Are you taking diuretics?
• Have you been hospitalized for heart failure within the past year?
• Has your doctor diagnosed you with heart failure or HFpEF?
• Has your doctor told you your heart is weak or not contracting strongly enough?
• Is your echocardiographic LV ejection fraction 40% or higher?

• Are you allergic to nickel?
• Is your hemoglobin less than 10g/dl?
• Is your systolic blood pressure higher than 170mmHg?
• Is your resting oxygen saturation less than 95%

SOPRANO

Purpose of the study: evaluates the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device implantation. The study also evaluates the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation. Finally, the study explores the potential effect of macitentan 10 mg as compared to placebo on right ventricular function, selected clinical events, and on renal function as measured by glomerular filtration rate (GFR), in subjects with PH after LVAD implantation.

Principal investigator: Shelley Hall, MD, FACC, FHFSA

For more information including inclusion and exclusion criteria, contact Amanda Doss at Amanda.Doss@bswhealth.org or 214.865.2419.

Victoria

This is a randomized, placebo-controlled, parallel-group, multi-center, double-blind, event driven trial of MK-1242 (vericiguat) in subjects with heart failure with reduced ejection fraction (HFrEF)

Purpose of the trial: The purpose of this study is to:

• Test the safety of the study drug, MK-1242 (vericiguat).
• Test the efficacy effect of the MK-1242 (vericiguat) compared with placebo (dummy tablets), added to best usual treatment

Inclusion
1. Have a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation.
2. Have a left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization.
3. Have brain natriuretic peptide (BNP) prior to randomization as follows:

• BNP
• Sinus Rhythm = 300 pg/mL
• Atrial Fibrillation = 500 pg/mL

Exclusion
1. Has concurrent or anticipated use of long-acting nitrates or NO donors including isosorbide dinitrate, isosorbide 5-mononitrate, entaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine.
2. Has concurrent use or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
3. Has symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days prior to randomization.
4. Has acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy.
5. Is awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates
receiving an implanted ventricular assist device.

Principle Investigator:Peter McCullough, MD, MPH

Who to contact for more information:
Laura Clariday Laura.Clariday@BSWHealth.org

Learn more about the study

Amulet

The purpose of this randomized controlled trial is to evaluate the safety and effectiveness of the Amulet device versus the commercially available Boston Scientific LAA closure (LAAC) device in subjects with non-valvular atrial fibrillation. The trial will test whether the device meaningfully improves health outcomes of all enrolled subjects through evaluation of the safety and effectiveness.

Inclusion
1. 18 years of age or older
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
3. At high risk of stroke or systemic embolism defined as CHADS2 score >2 or a CHA2DS2-VASc score of >3
4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6)
6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)
7. Able to comply with the required medication regimen post-device implant
8. Able to understand and willing to provide written informed consent to participate in the trial
9. Able to and willing to return for required follow-up visits and examinations

Exclusion
Please contact the research coordinator, Theresa Cheyne, at 817-922-2579.

Principle Investigator for Fort Worth site: Craig Delaughter, MD, PhD, FACC, FHRS

Who to contact for more information:
Theresa Cheyne (Office 817-922-2579)
Theresa.cheyne@bswhealth.org

STOP Persistent AF Clinical Trial

The STOP Persistent AF trial is currently enrolling participants to study the safety and efficacy of a dry-balloon device in those with recurrent, symptomatic atrial fibrillation (AFib) that has not been controlled by medication.

Inclusion:

• Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Age 18 or older (or older than 18 if required by local law)

Exclusion: Contact research coordinator, Cathy Headley, RN, 214.820.7108 or email Cathy.Headley@bswhealth.org.

Investigators: Peter Wells, MD and Kevin Wheelan, MD

For more information, contact research coordinator, Cathy Headley, RN at 214.820.7108 or email Cathy.Headley@bswhealth.org.

VELOXIS

Purpose of the retrospective study VELOXIS: This is a Phase II study evaluating the efficacy of tacrolimus extended release tablets to twice daily tacrolimus dosing regimen. Twenty-five adult recipients of a heart transplant will be enrolled in each group – one receiving a once a day dosing of Envarsus, the other receiving twice a day dosing of Prograf. Results of the two groups will be compared and evaluated for short term safety and tolerability of Envarsus. A follow-up safety assessment may be administered to follow up on any safety issues identified.

Principal Investigator: Shelley Hall, MD, FACC, FHFSA

For complete inclusion and exclusion criteria, please contact the study coordinators:
Amanda Doss, BS, CHES, Amanda.Doss@bswhealth.org, 214.865.2419 or
Michelle Clark, RN, Donna.Clark1@bswhealth.org, 214.820.1685.

LOWER A Study for Patients with Homozygous Familial Hypercholesterolemia

Purpose:
The registry is designed to evaluate the long-term safety and effectiveness of the medication lomitapide in clinical practice for patients with homozygous familial hypercholesterolemia.

Inclusion Criteria:

• Adult patients (age =18 years) who meet one of the following two criteria:
• Initiating treatment with lomitapide at the time of registry enrolment, or
• Initiated treatment with lomitapide within 15 months prior to enrolment into the registry and after lomitapide commercial availability in the country.

Exclusion Criteria:

• Patients who are receiving lomitapide in clinical trials or through compassionateuse where patients are followed under a separate protocol.
• Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received MA in the country of participation.

Primary Investigator: Peter McCullough, MD, MPH

Contact: Research Coordinator Laura Clariday Laura.Clariday@BSWHealth.org

SPYRAL OFF MED

Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in Patients with uncontrolled Hypertension in the Absence of Antihypertensive medications: SPYRAL Study.

Primary Investigator: James W. Choi, MD Sub-Investigator: Cara East, MD

For more information regarding this trial, please contact Soltero Cardiovascular Research Center at 214.820.2273

CLEAR

This study is designed to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

• Age: 18 to 85 years
• History, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, type 1 or type 2 diabetes, in women under the age of 65 or in men under the age of 60, or at high risk for a cardiovascular event
• Patient reported history of statin intolerance (inability to tolerate one or more statins, and unwilling to attempt a second statin or advised by a physician not to attempt a second statin)
• Fasting blood LDL-cholesterol equal to or greater than 100 mg/dL(2.6 mmol/L) at screening

• Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
• Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
• History of severe heart failure
• Uncontrolled hypertension or uncontrolled diabetes

Principal investigator: Cara East, MD, Medical Director, Soltero Cardiovascular Research Center

For more information regarding enrollment in this trial, please contact Merielle Boatman, at Merielle.Boatman@BSWHealth.org.

Apollo

Study to evaluate whether TMVR is non-inferior to conventional mitral valve surgery at one year for patients with severe symptomatic native mitral regurgitation. A multi-center, global, prospective, randomized, interventional pre-market trial, Apollo study subjects were randomized on a 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery to compare treatment efficacy.

Inclusion
To participate in this trial, the subject must meet ALL the following inclusion criteria.
1. Subject has severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards – Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation
2. Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement
3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Exclusions: There is a long list of exclusions. Please contact the research coordinator for additional information. Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org

Primary Investigator: Ravi Vallabhan, MD, FACC

For more information contact:

Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org


Learn more about the study

COAPT CAS

COAPT CAS is an extension of the COAPT Randomized Control Trial (RCT) under the same IDE as COAPT RCT.

After the enrollment of the COAPT RCT is complete, COAPT CAS will provide the opportunity to continue the evaluation of the safety and effectiveness of the MitraClip® NT System in patients who meet the COAPT inclusion/exclusion criteria. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more “real world” conditions. COAPT CAS will collect additional safety and effectiveness data to support the Premarket Approval (PMA) application of the labeling claims for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site’s local heart team as not appropriate for mitral valve surgery.

Inclusion:

• Subjects who have national Medicare coverage by CMS
• Symptomatic functional MR (=3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
• Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
• Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP =300 pg/ml or corrected NT-proBNP =1500 pg/ml
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
• Left Ventricular Ejection Fraction (LVEF) is =20% and =50%
• Left Ventricular End Systolic Dimension (LVESD) is =70mm

Exclusions: Contact research coordinator, Susan Aston, RN at 214-820-7358
Primary Investigator: Paul Grayburn, MD

Who to contact for more information: Susan Aston, RN 214-820-7358

CoreValve Low Risk Study

This study evaluates the procedural safety and efficacy of the Medtronic TAVR system on inpatients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR. Dallas location is the only Dallas area site with access for this trial.

Inclusion criteria:

• Severe aortic stenosis for symptomatic patients and for asymptomatic patients with specific criteria outlined for each (see link to clinicaltrials.gov for more information)
• Continued access for all low risk patients -- for a sub-study for patients with a bicuspid aortic valve.

• Significant ascending aortopathy requiring surgical repair
• Ascending aorta diameter greater than 4.0cm
• Age: less than 65 years

Early TAVR

A prospective, controlled, multi-center study; patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance (CS). Patients will be stratified by whether or not they are able to perform a treadmill stress test; in addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Inclusion
Patients must meet the following inclusion criteria to be included in the trial:
1. 65 years of age or older at time of randomization
2. Severe aortic stenosis defined as:

• Aortic valve area (AVA) =1.0 cm2 or AVA index =0.6 cm2/m2 AND
• Peak jet velocity =4.0 m/s or Mean gradient =40 mmHg

3. Patient is asymptomatic defined as:

1) Negative treadmill stress test. To be considered asymptomatic, the patient must not demonstrate any of the following during and/or after the test:

• Syncopal or pre-syncopal episode, including severe dizziness
• Angina

Limiting dyspnea or decreased exercise tolerance, defined as inability to reach 60% of age and sex adjusted metabolic equivalents of task (METs)

• Lack of increase or a drop in systolic blood pressure
• Significant ventricular arrhythmias (=4 consecutive ventricular premature beats)

OR
2) Per physician after thorough assessment of patient history if the patient is unable to perform a stress test.

4. LV ejection fraction =50%
5. Society of Thoracic Surgeons (STS) risk score =10
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site

Exclusions: Please contact the research coordinator for the exclusions: Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.

Primary Investigator: Robert M. Stoler, MD, FACC, FSCAI

For more information, please contact:

Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org.

EXCEED

A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement.

This study’s objective is to establish the safety and effectiveness of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement(SAVR).

Inclusion:

• Subjects with symptomatic, severe, calcific aortic stenosis and appropriate iliofemoral anatomy who are at intermediate operative risk

• Please contact the research coordinator for details.

Primary Investigator: Robert Stoler, MD, FACC, FSCAI
For more information contact Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org

Low-Risk Bicuspid Valve Trial

TAVR with Medtronic TAVR with Medtronic TAVR System in Patients with Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (SAVR).

This study’s objective is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR.

Inclusion:

• Please note: there is inclusion criteria for both symptomatic and asymptomatic patients. Please contact the research coordinator for details.

• Significant ascending aortopathy requiring surgical repair
• Ascending aorta diameter greater than 4.0 cm
• Age less than 65

Primary Investigator: Robert Stoler, MD, FACC, FSCAI
For more information contact Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org

REFLECT

The purpose of the REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation is to study the Keystone Heart TriGuard™ HDH, an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation. The objective of the study is to assess the safety and efficacy of the TriGuard™ HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI. Subjects with indications for TAVI and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuard™) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.

For inclusions or exclusion or additional information, please contact the research coordinator for additional information. Emily Laible, RN, BSN, CCRC, at 214-820-9903 or email at Emily.Laible@BSWHealth.org

Primary Investigator: Robert M. Stoler, MD, FACC, FSCAI

SUMMIT

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT).

Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation. Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria and be approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial.

Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site.

Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device.

Primary Investigator: Paul Grayburn, MD
For more information, please contact: Susan Aston, RN 214.820.7358