Carilion Clinic Cardiology research spans the spectrum from large, multicenter randomized clinical trials to smaller studies conceived and conducted by cardiologists from Carilion Cardiovascular Institute. Our studies are sponsored by the National Institutes of Health, by device and pharmaceutical companies, by agencies such the American Heart Association and by foundations. Our overall goal is to participate in and conduct studies that will answer important questions in cardiovascular medicine.

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Structural Heart Clinical Trials

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Aortic Valve

The EXPAND II TAVR study is designed to determine if we should be treating aortic stenosis (narrowing of the aortic valve) sooner that current guidelines suggest. This study will compare patients with symptomatic moderate aortic stenosis having their valve replaced now versus waiting until the valve becomes severely narrowed.

The BASELINE trial is to compare Balloon Expandable Transcatheter Valves (Evolute by MEDTRONIC) with Self Expanding Valves (Sapien3- EDWARDS) for degenerated bioprosthetic heart valves.

Mitral Valve

The APOLLO trial is an alternative mitral valve replacement procedure using the Medtronic Intrepid system in patients with severe symptomatic mitral regurgitation that are unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention.

The ENCIRCLE trial looks to establish the safety of mitral valve replacement through the femoral artery in the leg for patients that are not suitable for commercially available surgical or transcatheter treatment options

Cerclage EFS is an early feasibility study evaluation of a new technique and device that treats mitral valve leakage caused by damaged heart muscle in the left ventricle.

Tricuspid Valve

The CLASP II Tricuspid Regurgitation trial evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with agreement by the local Heart Team.

Paravalve Leak

The PARADIGM trial is evaluating the paravalvular leak closure with the Amplatzer Valvular Plug occluder for Interventional transcatheter closure for PVL with surgical biological and mechanical heart valve.

Left Atrial Appendage

The ASAP II trial is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including post-implant medication regimen, for subjects with non-valvular afib who are deemed not eligible for anti-coag therapy to reduce the risk of stroke.

The CONFORM Pivotal Trial is a evaluation of the safety and effectiveness of the Conformal CLAAS System for left atrial appendage closure device

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Heart Failure

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Heart failure, sometimes known as congestive heart failure, occurs when your heart muscle doesn't pump blood as well as it should. Certain conditions, such as narrowed arteries in your heart (coronary artery disease) or high blood pressure, gradually leave your heart too weak or stiff to fill and pump efficiently.

The DISCOVER trial is a prospective registry study to assess real-world patient characteristics, treatment patterns, and longitudinal outcomes in patients receiving Mavacamten and Other treatments for symptomatic obstructive hypertrophic cardiomyopathy.

This study investigates the use of the AccuCinch Ventricular Restoration System for heart failure patients who continue to have symptoms despite medical therapy, the AccuCinch system is the only completely transcatheter procedure designed to restore, support and strengthen the enlarged left ventricle.

The HEART FID trial is for heart failure patients with low iron levels.

The ARTISAN clinical trial looks at the ability of drug therapy using Treprostinil to reduce right ventricular remodeling and improve function of the right ventricle for individuals with pulmonary arterial hypertension.

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Coronary Artery Disease

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Coronary artery disease is the narrowing or blockage of the coronary (heart) arteries. This condition is usually caused by atherosclerosis. Atherosclerosis is the buildup of cholesterol and fatty deposits (called plaques) inside the arteries.

The IMPROVE clinical trial is investigating clinical outcomes using an intravascular ultrasound-guided stent implantation in coronary vessels vs angiography-guided stent implantation.

The ROADSTER 3 study is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients that require carotid artery revascularization.

VICTORION-INCEPTION is a study using aggressive low-density lipoprotein cholesterol management using the drug Inclisiran vs Usual Care in patient with recent Acute Coronary Syndrome

The purpose of the SAFE STEMI study is to simultaneously address four potential advances in ST-elevation myocardial infarction (STEMI) care for patients at least 65 years old who require a procedure to open their narrowed blood vessel(s) in an effort to see if these advances can improve the outcome for these patients.

The Protect IV trial utilizes a heart pump to support patients undergoing percutaneous coronary intervention, a minimally invasive procedure to open blocked coronary (heart) arteries.

The WARRIOR trial is for women with non-obstructive heart disease showing symptoms of ischemia, who will receive either high-dose heart medications or regular-dose medications.

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Humanitarian Use Devices

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The PAPYRUS Covered Coronary Stent System is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5mm to 5.0mm in diameter. The effectiveness of this device for this use has not been demonstrated. If you want to use this device for other indications IRB approval is required.

The AMPLATZER™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.

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Cardiothoracic Surgery Research

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Carilion’s cardiothoracic surgery researchers focus on diseases of the vascular system—or arteries, veins and lymphatic circulation—managed by medical therapy, minimally invasive catheter procedures and surgical reconstruction.

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