Enrolling Clinical Trials

  • Principal Investigator:

    Robert J. Sommer, MD
    The purpose of this study is to collect more information about the GORE CARDIOFORM Septal Occluders (GSO device) treatment to close the Patent Foramen Ovale (PFO) to reduce the risk for another stroke.
  • Principal Investigator:

    Ajay J. Kirtane, MD, SM
    RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed todemonstrate the effectiveness (how well it works) and safety of the Paradise Renal Denervation System in hypertensive subjects (subjects with high blood pressure).
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is designed for patients with severe, symptomatic mitral regurgitation who are not candidates for conventional mitral repair.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a prospective, multi-center open label first in human clinical study aimed at demonstrating safety and technical performance of the Cardiovalve device to minimize tricuspid regurgitation. Tricuspid regurgitation is a disorder in which the valve does not close tight enough. This problem causes blood to flow backward into the right upper heart chamber (atrium) when the right lower heart chamber (ventricle) contracts. The purpose is to evaluate the safety and technical performance of the Cardiovalve System to successfully treat patients with severe tricuspid regurgitation. The tricuspid...
  • Principal Investigator:

    Dimitrios Karmpaliotis, MD
    A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are for the intended use of facilitating the safe and effective crossing of coronary arteries that are blocked and placement of conventional guidewires beyond the narrowed artery. The data captured in this study will be used to support U.S. Food...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL Systems implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as standard of care) compared to OMT alone in participants withsymptomatic severe tricuspid regurgitation who may not be ideal candidates for tricuspid valve surgery (tricuspid valve repair that is performed via openheart surgery) and may be eligible...
  • Principal Investigator:

    Sahil A. Parikh, MD
    This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the therapies that has been used to treat PAD is balloon angioplasty. It is a procedure where a small balloon is inserted into the blood vessel next to the area that is narrowed and inflated temporarily. The inflated balloon opens up the narrowing by pushing on the wall of the blood vessel to restore blood flow...
  • Principal Investigator:

    Andrew Jeffrey Einstein, MD, PhD
    We are seeking healthy volunteers and people who have tested positive for COVID-19 in the past. Our study is looking at how coronavirus affects the heart after recovery. If you enroll, you will be given an echocardiogram and a cardiac magnetic resonance imaging (MRI) scan, and you will be asked to provide a blood sample. An echocardiogram is a test that uses sound waves to get a picture of your heart. A cardiac MRI scan uses radio waves to get another kind of picture of your heart. For the MRI, you will receive an injection of a contrast agent, which is safe for qualified participants. There...
  • Principal Investigator:

    Andrew Jeffrey Einstein, MD, PhD
    We are seeking healthy volunteers and people who have tested positive for COVID-19 in the past. Our study is looking at how coronavirus affects the heart after recovery. If you enroll, you will be given an echocardiogram and a cardiac magnetic resonance imaging (MRI) scan, and you will be asked to provide a blood sample. An echocardiogram is a test that uses sound waves to get a picture of your heart. A cardiac MRI scan uses radio waves to get another kind of picture of your heart. For the MRI, you will receive an injection of a contrast agent, which is safe for qualified participants. There...
  • Principal Investigator:

    Tamim M. Nazif, MD
    Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on the market. The device delivers percutaneous sutures (administers stitches through the skin) for the closure of large bores created in the common femoral artery access site during your endovascular aneurysm repair surgery. The objective of...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The early feasibility study (EFS) of the Cardioband Tricuspid System is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for transcatheter tricuspid valve reconstruction with the Edwards Cardioband Tricuspid Valve Reconstruction System by the local Heart Team.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The study is designed to to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
  • Principal Investigator:

    Robert J. Sommer, MD
    This study will evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using a device called the GORE CARDIOFORM Septal Occluder. A patent foramen ovale (PFO) is a hole in the heart that didn't close the way it should after birth. During fetal development, a small flap-like opening the foramen ovale is normally present in the wall between the right and left upper chambers of the heart (atria). Most patients with a PFO do not have any symptoms. However, the condition may play a role in migraine headaches and it increases the risk of stroke, transient ischemic attack (stroke...
  • Principal Investigator:

    Ajay J. Kirtane, MD, SM
    This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
  • Principal Investigator:

    Sanjum Sethi, MD
    This is a prospective, multi-center, observational, post-market study that will evaluate the safety and procedural success of performing transradial access for treatment of atherosclerotic lesions in the lower extremities. This research study will collect outcome data of patients undergoing percutaneous endovascular treatment of Peripheral Artery Disease (PAD) in the lower extremities via radial artery access. Additionally, the complication rates and patient satisfaction in these patients who are having a standard procedure for PAD will be assessed.
  • Principal Investigator:

    Tamim M. Nazif, MD
    The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved in the United States by the Food and Drug Administration (FDA) in 2014, the procedure and valve iterations have become increasingly efficient with reducing complications. The EvolutTM PRO valves outer pericardial wrap has shown to enhance...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular disease in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) require the need for treatment. This is a study that is collecting safety and effectiveness data in a high or extreme surgical risk patient population with symptomatic, severe native AS and who meet eligibility criteria for implantation of the PorticoNG valve. The Portico NG Valve (along with the delivery and loading...
  • Principal Investigator:

    Amirali Masoumi, MD
    The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
  • Principal Investigator:

    Dimitrios Karmpaliotis, MD
    This study is trying to determine if using Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides the imaging support while directing the stent device via the artery in your groin or arm to the coronary artery. During the procedure iodine contrast fluid is repeatedly injected in your coronary arteries to visualize the coronary arteries on X-ray. This lasts only for a short...
  • Principal Investigator:

    Sahil A. Parikh, MD
    The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow can be restored. The balloon is then...
  • Principal Investigator:

    Torsten Peter Vahl, MD
    This is a multicenter, prospective randomized study to determine the safety and efficacy of the Watchman device in patients with irregular heart beat undergoing a less invasive procedure than open heart surgery called Transcatheter Aortic Valve Replacement (TAVR). In this procedure, an x-ray is used to visualize and guide the Watchman device via a catheter to replace the heart valve. This is done for patients with aortic stenosis (AS) where there is reduced blood flow, pain and fatigue because the blood has to work harder to pump blood due to narrowed valves in the blood vessels. The watchman...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The goal of this study is to evaluate the safety and performance of the EVOQUE Valve in patients with at least moderate tricuspid regurgitation and signs of, symptoms from or prior heart failure hospitalizations for tricuspid regurgitation...
  • Principal Investigator:

    Jeffrey Moses, MD
    The purpose of this research study is to evaluate if it is safe and feasible to use the Impella Hemodynamic Platform to measure and display hemodynamic parameters (measurements of how much pressure the heart is generating and how much blood your heart is pumping) during PCI procedures. PCI is a surgical procedure that uses a catheter (a thin flexible tube) to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. The Impella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition where the blood draws back into the mitral valve causing the heart to pump harder. The population of patients are also those who are not eligible for conventional mitral valve surgery.For participants in this study population, the doctors have...
  • Principal Investigator:

    Tamim M. Nazif, MD
    This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from cows to direct the flow of blood through the heart the way a normal valve would if it was healthy. This artificial valve is delivered into the heart by a small flexible tube (catheter) that is about as big around as a pencil. This flexible...
  • Principal Investigator:

    Sahil A. Parikh, MD
    This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore blood flow) and whether that delivery helps to prevent re-narrowing of the blood vessel. If you are 18 and have a narrowing or blockage of the blood vessels (arteries) in your leg which your physician has determined needs to be treated with...
  • Principal Investigator:

    Ajay J. Kirtane, MD, SM
    This is a prospective, multi-center, single-arm, phased clinical study intended to provide pivotal data for device approval. The study is intended to demonstrate that the device, the SoundBite Crossing System Coronary can allow the passage of devices intended to treat a Chronic total occlusion (CTO). When arteries that supply blood to the heart become completely blocked, they are referred to as Chronic total occlusion (CTO). Although most blockages in the heart vessels can be opened by interventional cardiologists using minimally invasive techniques, opening completely blocked vessels remains...
  • Principal Investigator:

    Nir Uriel, MD, MSc
    The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data suggest the HeartMate 3 may not require as much anticoagulation (blood thinners) as are normally used. This study will test if patients need aspirin together with warfarin or just warfarin alone.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    Assessing the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.
  • Principal Investigator:

    Robert J. Sommer, MD
    This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a research study to evaluate the use of a device to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis. This is an international, multicenter, randomized, open-label, clinical trial comparing the safety and effectiveness of TAVR(Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 THV (transcatheter heart valve) and medical therapy to medical therapy alone in HF patients with moderate AS. You will...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The goal is to evaluate the safety and effectiveness of the TriClip device in patients with severe Tricuspid Regurgitation (TR) and are deemed greater risk for mortality with tricuspid valve surgery.