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Baylor Scott & White Heart and Vascular Institute – Clinical Trials

Atrial Fibrillation

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 .

Cardiorenal Syndrome

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.

Coronary Artery Disease

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

Heart Failure

ALN-TTR02-007 – Alnylam

Descripton: A study for patients with hATTR amyloidosis and polyneuropathy.

Inclusion criteria:

  • Documented hATTR Amyloidosis with polyneuropathy
  • Karnofsky performance status ?50%

Exclusion criteria:

  • Active infection requiring antivirals or antimicrobial therapy
  • New York Association Heart Failure Classification >2
  • PND Stage IV
  • Experienced acute coronary syndrome within the past 3 months
  • Uncontrolled cardiac arrhythmia or unstable angina

For more information, contact study coordinator: Michelle Clark, RN at michelle.clark1@BSWhealth.org .

Primary Investigator: Parag Kale, MD

CAPACITY HFpEF

Descripton: A multicenter, randomized, double-blind, placebo-controlled, Phase 2 study evaluating the safety and efficacy of different doses of IW-1973 over 12 weeks in patients with heart failure with preserved ejection fraction.

Inclusion criteria:

1. Patient has signed an informed consent form (ICF) before any study-specific procedures are performed.
2. Patient is an ambulatory male or female =50 years old at the Screening Visit.
3. Patient has heart failure with ejection fraction (EF) of =45% as assessed within 12 months of the Screening Visit, without previously documented EF of >40%.
4. NYHA Class II-IV symptomology
5. At least 2 risk factors for HFpEF including: type 2 DM, hypertension, BMI >30, or aged =70 years
6. May have permanent or persistent atrial fibrillation (total number of patients limited to 64)

Exclusion criteria:

1. Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before Randomization.
2. Patient has had cardiac transplantation or has cardiac transplantation planned during the study.
3. Patient has severe chronic obstructive pulmonary disease (COPD) as defined by chronic oxygen dependence. Nighttime oxygen is not exclusionary.
4. Patient has had heart failure hospitalization with discharge within 30 days before the Screening Visit.
5. Patient has history of uncorrected congenital cardiac disease affecting LV function.
6. Patient has uncorrected thyroid disease.

For more information, contact Taylor Poyner, BSN, RN, at Taylor.Poyner@BSWhealth.org .

Primary Investigator: Cesar Guerrero-Miranda, MD

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

GALACTIC HF

Descripton: A double-blind, randomized, placebo-controlled, multicenter study to assess the efficacy and safety of Omecamtiv Mecarbil on mortality and morbidity in subjects with chronic heart failure With reduced ejection fraction.

Inclusion criteria:

  • Age 18-85
  • History of chronic HF (minimum of 30 days)
  • LVEF = 35%, per subject's most recent medical record, within 12 months prior to screening. The most recent qualifying LVEF must be at least 30 days after any of the following, if applicable: 1) an event likely to decrease EF (eg, myocardial infarction, sepsis); 2) an intervention likely to increase EF (eg, cardiac resynchronization therapy, coronary revascularization); or 3) the first ever presentation for HF.
  • NYHA class II to IV
  • Managed with HF SoC therapies
  • Currently hospitalized with primary reason of HF OR one of the following events within 1 year to screening: 1) hospitalization with primary reason of HF; 2) urgent visit to ED with primary reason of HF
  • BNP >125 pg/mL, or NTproBNP >400pg/mL; for subjects with afib cutoff levels are BNP >375 pg/mL or NTproBNP >1200 pg/mL; subjects receiving ARNi's, must use NTproBNP assessment

Exclusion criteria:

Please contact the study coordinator as the list is extensive.
For more information, contact Taylor Poyner, BSN, RN, at Taylor.Poyner@BSWhealth.org .

Primary Investigator: Susan Joseph, MD

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.

PRESERVED HF

Descripton: Effects of Dapagliflozin on biomarkers, symptoms and functional status in patients with Type 2 diabetes or pre-diabetes, and preserved ejection fraction heart failure.

For additional information: https://www.saintlukeskc.org/locations/saint-lukes-mid-america-heart-institute
For the complete list of inclusions and exclusions, please contact the Dallas campus coordinator: Taylor Poyner, BSN, RN, at Taylor.Poyner@BSWhealth.org .

Primary Investigator: Susan Joseph, MD

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

Heart Rhythm Disorders

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.

Hypercholesterolemia

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

Valve Disease

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, BSW, CCRC
214-820-9903

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

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: Rebecca Baker, RN, at 214-820-7965.
Primary Investigator: Robert M. Stoler, MD, FACC, FSCAI

For more information, please contact: Rebecca Baker, RN, at 214-820-7965.

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


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