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Clinical Trials

Overview

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
1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
3. Indicated for chronic P2Y12 platelet therapy inhibitor
4. Is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay (criterion is only applicable where general anesthesia is planned for the study procedure)
5. Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
6. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
7. Implanted with a mechanical valve prosthesis
8. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
9. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
10. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
11. Myocardial infarction (MI) within 90 days prior to randomization
12. New York Heart Association Class IV Congestive Heart Failure
13. Left ventricular ejection Fraction (LVEF) <30%
14. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis
15. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
16. History of idiopathic or recurrent venous thromboembolism
17. Left atrial appendage is obliterated or surgically ligated
18. Thrombocytopenia or anemia requiring transfusions
19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
21. Subject is pregnant or pregnancy is planned during the course of the investigation
22. Active endocarditis or other infection producing bacteremia
23. Subject has a known malignancy or other illness where life expectancy is less than 2 years

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

Overview

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:
Rebecca Baker, RN (Office 214-820-7965)

Overview

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:
Rebecca Baker, RN (Office 214-820-7965)

Overview

MOMENTUM 3 IDE 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 Natasia Weiss at Natasia.Weiss@BSWHealth.org.

Overview

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.


Prior Clinical Trials Information

SPIRE 1 and 2

The purpose of this research study was to compare the effects of the study drug, bococizumab (also called PF-04950615), with a placebo to find out how effective and safe bococizumab is in preventing major cardiovascular events, (heart attacks, strokes, and hospitalization for chest pain), when added to other cholesterol treatments.

Primary Investigator
Peter McCullough, MD

Symplicity

Baylor researchers are studying a new approach that could help normalize blood pressure-without medication. The Symplicity trial is testing a minimally invasive procedure known as renal denervation. The experimental procedure uses heat that is generated by radio frequency to disrupt nerve communication to and from the kidneys. This can reduce over activity in the sympathetic nervous system, a frequent cause of chronic high blood pressure.

CoreValve Transcatheter Valve

The Baylor team has now implanted 14 of these valves (16 randomized), which are implanted transcutaneously, for severe or critical aortic stenosis. This provides an option for treatment of patients who could not undergo open-heart surgery.

Primary Investigators
Robert Stoler, MD
Robert F. Hebeler, MD
Paul Grayburn, MD

VIRGO

The Baylor sites enrolled over 70 patients in this observational registry of women and men (enrolled 2:1) under the age of 55 who have had proven myocardial infarctions. Study includes demographics, psychosocial factors, biomarkers, and gene testing.

Primary Investigators
Deepika Gopal, MD
Cara East, MD


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