Structural Heart Disease Clinical Trials

Small Annuli Randomized to Evolut™ or SAPIEN™ Trial (SMART)

This is a prospective, multi‐center, international, randomized controlled, post‐market trial. The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV).

For more information:

SAPIEN™ M3 System Transcatheter Mitral Valve Replacement via Transseptal Access (ENCIRCLE)

This is a prospective single-arm, multicenter and adaptive design study. The objective of this study is to establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ MR for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.

For more information:

Edwards PASCAL Transcatheter Valve Repair System Pivotal Trial (CLASP II TR)

Tricuspid Regurgitation (TR) is a condition in which the heart’s tricuspid valve does not close tightly, which causes blood to flow backwards in the incorrect direction during part of the cardiac cycle. This condition increases the workload on the heart, and if left untreated, it can increase the risk of worsening heart failure. The tricuspid valve has three leaflets. The device implant will be positioned to grasp each of these leaflets and bring them together to help reduce the leak in the valve. The PASCAL implant will act as a filler to help reduce abnormal backflow of blood in the heart.

For more information:

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

The purpose of this trial is to evaluate a new investigational device called the Tendyne™ Mitral Valve System. The Tendyne Mitral Valve System is designed for the treatment of a diseased, damaged or malfunctioning mitral valve. This trial will collect information on how safe and effective this device is to treat a leaking mitral valve as compared to the commercially available (approved by the U.S. Food and Drug Administration (FDA)) MitraClip® System. The MitraClip System consists of a delivery catheter and an implantable Clip that is designed to repair the mitral valve by clipping the two leaflets together. The trial will include patients with moderate to severe or severe mitral valve which are not amenable to treatment with MitraClip as well as patients with symptomatic mitral valve disease due to significant calcium deposition on the mitral valve. These patients will be treated with the Tendyne Mitral Valve System and information will be collected for evaluating the safety and efficacy of this device in these patients.

For more information:

Heart Transplant Clinical Trial

Surveillance HeartCare® Outcomes Registry (SHORE)

The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about your heart transplant such as test results, biopsy results, and outcomes, storing that information in a database, and using that information for research. Additional blood will be collected for the purposes of this study. The AlloMap® blood test has been cleared by the US Food and Drug Administration (FDA) and available for use since 2005. AlloMap measures the levels of 20 genes in your blood. Your transplant team uses the AlloMap test score, along with other standard tests, to find out how well your body is accepting your new heart. AlloSure-Heart® is another blood test that assesses the transplanted heart for injury. When injury occurs, a special type of DNA called donor-derived cell-free DNA (dd-cfDNA) is released into your blood. AlloSure-Heart measures the amount of dd-cfDNA in the blood. AlloSure-Heart provides information that can help your primary health care provider determine the right treatment for you.

For more information:

Interventional Heart Failure Clinical Trials

A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA ) Class III Heart Failure Patients (PROACTIVE HF)

This is a prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients. The Cordella PA Sensor will be implanted in conjunction with a right heart catheterization (RHC) procedure and the device will be introduced via percutaneous venous access to the pulmonary artery.

For more information:

Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction (ANTHEM HFrEF)

ANTHEM-HFrEF is a multi-center, open-label, randomized controlled clinical trial with an adaptive design. Patients with symptomatic heart failure and reduced left ventricular ejection fraction will be enrolled and randomized 2:1 to receive VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy alone (control arm).

Subjects in the therapy arm will receive continuous, periodic VNS stimulation after surgery is completed, and will undergo visits for VNS up titration over a period of 3 months. Subjects in the control arm will also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm.

For more information:

Reducing Lung Congestion Symptoms Using the V-Wave Shunt in Advanced Heart Failure (RELIEVE HF)

Certain types of heart failure may lead to retention of extra fluid that causes an increase in the pressure on the left side of the heart. The increased pressure leads to congestion in the lungs. Common symptoms of heart failure can be due to the extra fluid or congestion and include shortness of breath, fatigue, and swelling of the feet or legs. The study shunt (V-Wave Interatrial Shunt) is implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart. The small opening in the center allows a small amount of blood to flow from the top left chamber to the top right chamber of the heart. By transferring or “shunting” this small amount of blood, the increased pressure in the left side of the heart is reduced, which is expected to reduce congestion in the lungs and improve symptoms of heart failure. These patients will be treated with the V-Wave Interatrial Shunrt and information will be collected for evaluating the safety and efficacy of this device in these patients.

For more information:

Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

The purpose of this research study is to evaluate a heart pressure sensor called the CardioMEMS™ PA Sensor (referred to as “the device”) within the CardioMEMS™ HF System. This small sensor is implanted into the heart on the tip of a catheter and through a vein to measure pulmonary artery pressure. The CardioMEMS™ HF System is approved by the U.S. Food and Drug Administration (FDA) for a select group of patients. The study will help to determine if using the device’s data for other indicators of heart failure may reduce heart failure related hospital-admissions. You may be eligible if you are at risk of having episodes of worsening heart failure.

For more information:

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)

A Left Ventricular Aneurysm (LVA) is a large area of the left ventricle of the heart that is damaged and no longer ejects blood efficiently. An LVA may result from complications after a heart attack, physical trauma, cardiac disease, or a congenital heart defect. The Revivent TC System study is being conducted to test an investigational device designed to repair a LVA without the use of a heart-lung machine or opening the chest/heart chamber. The device works by placing a tuck in the heart where there is scar. This shortens the distance across the heart and decreases the tension, or stress, on the working heart muscle.

For more information:

Mechanical Circulatory Support Clinical Trials

Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES)

The HeartMate 3 is a U.S. Food and Drug Administration (FDA) approved mechanical heart pump device that pumps blood when the heart cannot. The HeartMate 3 requires pharmaceuticals to keep blood from clotting (also known as “blood thinners,” anticoagulants, and antiplatelet medications). Two blood thinner pharmaceuticals are currently used with the HeartMate 3: aspirin and warfarin. This study is investigating the efficacy comparison between the combination of aspirin and warfarin, as compared to warfarin alone.

For more information:

Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction (STEMI-DTU)

The study will evaluate the use of a temporary circulatory assist device (heart pump) to support the heart with pumping blood during treatment of the heart attack. This device is called the Impella® CP system or the Impella CP with SmartAssist System (“study device”). The study device has been approved by the U.S. Food and Drug Administration (FDA) for commercial use in the United States to treat patients with different conditions, and who need assistance pumping blood from the heart to the rest of the body.

For more information:

Idiopathic Pulmonary Fibrosis Clinical Trial

A Study to Test the Efficacy and Safety of Inhaled TD139 in Subjects with Idiopathic Pulmonary Fibrosis (GALACTIC-1)

Galecto Biotech AB has begun a study of an investigational drug (also known as the “study drug”) called TD139 as a possible treatment for idiopathic pulmonary fibrosis (IPF). The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to the placebo.

For more information:

A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (REBUILD)

This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. The primary objective in this study is to identify the optimal dose and verify the efficacy of iNO in subjects with pulmonary hypertension and pulmonary fibrosis currently receiving treatment with long term oxygen therapy.

For more information:

Chronic Obstructive Pulmonary Disease Clinical Trial

A Prospective, Multicenter, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support (VENT-AVOID)

The purpose of this research study is to test the safety and efficacy of using a new medical study device called the Hemolung Respiratory Assist System (Hemolung). This study will compare treatment with the Hemolung system to standard medical treatment for people with (Chronic Obstructive Pulmonary Disease (COPD) who have been admitted to a hospital intensive care unit (ICU) because of severe difficulty in breathing. The Hemolung is an investigational medical device that has not yet been approved by the U.S. Food and Drug Administration.

For more information: