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Clinical Trials

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Current Clinical Trials

ABOUT THE CENTER FOR CLINICAL RESEARCH

If you are considering taking part in a clinical trial at The Texas Heart Institute, we encourage you to contact us. All trials must protect patient safety first and foremost. Our investigators carefully follow protocols designed to maximize benefits and reduce risks. We provide eligible patients with an informed consent process where the patients can ask questions and receive study information before deciding to participate.  You might be a good fit for one of our current trials if you have any of the following conditions:

Acute or Chronic coronary syndrome
Atherosclerotic cardiovascular disease (ASCVD) “blocked arteries”
Atrial fibrillation
Balloon Angioplasty
Cardiac Catheterization
Cardiomyopathy
Elevated cholesterol
Endovascular abdominal aortic aneurysm repair (EVAR)
Heart failure
Recent heart attack
Stent Placements
Transcatheter aortic valve repair (TAVR)

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ACT Study

The ACT Study is designed to identify the optimal time to check activated clotting time (ACT) after heparin bolus during percutaneous coronary intervention (PCI).

Apple Watch Study

This study is designed to test the feasibility of the Apple Watch as a fast self-check tool for detection of heart attack.

BiVACOR (NCT06174103)

The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life.

CATO (NCT06145035)

A Phase IIA, randomized, double blind, placebo-controlled study of single versus repeated intravenous administration of umbilical cord derived mesenchymal stromal cells (UC-MSCs) in patients with ischemic cardiomyopathy.

CLEAN-PE (NCT06189313)

The purpose of this study is to evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

COSIRA-II (NCT05102019)

This is a study to demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.

DCM II TRIAL (NCT04476901)

A Phase IIB, randomized, placebo-controlled, multicenter study of the comparative efficacy and safety of administration of allogeneic mesenchymal stem cells versus placebo in patients with non-ischemic dilated cardiomyopathy.

DRAIN-HF (NCT05677100)

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF). Aortix is a circulatory support device for chronic heart failure (HF) patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.

EVOID-AS (NCT05143177)

An Adaptive Phase 2/3 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel, 3 Arm Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient’s Calcific Aortic Valve Disease with Mild to Moderate Aortic Stenosis (EVOID-AS).

FMD Registry

The North American Registry for Fibromuscular Dysplasia is a global research effort designed to collect clinical data and provide resources for Fibromuscular dysplasia (FMD) patients and healthcare providers. Registries collect information that can be used to study and learn more about a specific condition. This information will help improve the treatment of patients with FMD in the future.

Contact Us to Learn More at women@texasheart.org

 

Houston HeartReach

The Houston HeartReach Registry is a community-wide registry research study that aims to make improvements in heart disease prevention, diagnosis, and treatment for all women to help identify trends in heart-health risks in a diverse population of women, develop future clinical trials, and recruit women for future research studies.

PerQseal® IDE Clinical Study – PATCH (NCT05653336)

A multicentre, single-arm, pivotal study to evaluate the safety and efficacy of the Vivasure PerQseal® Closure Device System when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 f sheaths in patients undergoing percutaneous catheter-based interventional procedures.

Phenotype Study

The Cardiogenic Shock Phenotyping for the Identification of Cardiac Recovery Biomarkers Study (Phenotype Study) is designed to define the incidence of hemodynamic and functional myocardial recovery in an unbiased patient population treated with Acute Mechanical Circulatory Support (AMCS) for cardiogenic shock.

PREVAIL (NCT05202509)

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy to reduce the risk of cardiovascular death, myocardial infarction, stroke and non-elective coronary revascularization.

The PROTECT IV Trial (NCT04763200)

Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The Protect IV Trial

Relieve HF (NCT03499236)

Reducing Lung congestion symptoms using the V-wave shunt in Advanced Heart Failure.

Stem Cell Therapy vs Standard of Care in Cardiomyopathy (NCT02962661)

Randomized 3-Arm Trial with Standard of Care Alone vs either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) plus Standard of Care in Patients with Anthracycline-Associated Cardiomyopathy