Enrolling Clinical Trials

  • Principal Investigator:

    Jeffrey W Moses, MD
    This is a prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. The study is being done to look at the safety and effectiveness of the AgentTM drug-coated balloon compared to standard (non-drug coated) balloons also known as balloon angioplasty for the treatment of your re-narrowed blood vessel. In a balloon angioplasty, a specially designed thin wire called a catheter with a tiny balloon is carefully guided through the artery to the blockage. It is then inflated to widen the opening and increase blood flow to the heart. A stent is often...
  • Principal Investigator:

    Robert J. Sommer, MD
    This is a prospective, multicenter, open label, single-arm study that seeks to confirm and describe thesafety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated withpercutaneous, transcatheter PFO closure plus anti-platelet medical management compared toperformance goals derived from REDUCE study results.
  • Principal Investigator:

    Tamim M. Nazif, MD
    This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-expanding implant that restores competency in a sclerotic aortic valve. To implant the device, a surgical incision is made in the femoral vein (incision in the upper leg between the knee and the hip). A catheter is advanced into the heart access...
  • 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:

    Robert J. Sommer, MD
    This is a prospective, randomized, multi-center global investigational study. The primary objective is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACs - drugs that inhibits clotting) in patients with Atrial Fibrillation (AF) - irregular heart rhythm caused by other things, such as high blood pressure or an overactive thyroid gland.
  • 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 with symptomatic 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 to collect information about the symptoms and treatments of patient who have severely clogged arteries and treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. If you choose to be part of this research, we will ask you to be involved in office visits at 6, 12 and 24 months as well as follow up at 36, 48 and 24 months will be completed in office or remotely. Your involvement in the research will last for 5 years. There are no or minimal risks from participating in this study...
  • Principal Investigator:

    Nir Y. Uriel, MD
    The objective of this clinical evaluation is to assess the safety and initial effectiveness of an interventional procedure involving ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
  • Principal Investigator:

    Andrew Jeffrey Einstein, MD
    Phase 3 open-label, multicenter Study of Flurpiridaz Injection for PET Imaging for assessment of Myocardial perfusion in patients referred for Invasive Coronary Angiography because of suspected Coronary Artery Disease
  • Principal Investigator:

    Hirad Yarmohammadi, MD
    We are doing this study to gather information on participants returning at time of Cardiovascular Implantable Electronic Device (CIED) change-out or revision who underwent a device implantation with either a CanGaroo envelope, Tyrx envelope, or no envelope. A CIED is a device implantable inside the body, able to conduct pacing of the heart and therefore capable of correcting most life-threatening abnormal heart rhythms. People who have had surgery to implant a medical device that helps their heart, may have had their surgery done in slightly different ways. In this study, the investigators...
  • Principal Investigator:

    Sahil A. Parikh, MD
    This is a prospective, multicentre observational study to evaluate the BioMimics 3D Vascular Stent System in the treatment of peripheral arterial disease. The purpose of the Study is to collect detailed information on the BioMimics 3D stent performance when used according to standard medical care. A Minimum of 500 patients will be enrolled in a two-year recruitment period at up to 40 sites. Patients will be evaluated at 30 days then 12, 24, and 36 months.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial, each subject will be followed until their 10-year visit. Clinical Investigation visits will occur at Screening (for determination of eligibility), Baseline (after confirmation of eligibility), Index Procedure, Discharge, 30 days, 6 months, 1...
  • Principal Investigator:

    Robert J. Sommer, MD
    This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of a new device, called the Carag Bioresorbable SeptalOccluder (CBSO) device when used to treat Atrial Septal Defect (ASD). ASD is a condition that occurs at birth where there is a hole in the two upper chambers of the heart.
  • Principal Investigator:

    Ajay J. Kirtane, MD
    This study is trying to determine if using a 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 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:

    Jeffrey W 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...
  • Principal Investigator:

    Nir Y. Uriel, MD
    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:

    Susheel Kumar Kodali, MD
    This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored byPi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement will be treated with the Leaflex Performer in up to 7 clinical sites. All enrolled patients will be followed up at 30 days and at 3, 6, 9 and 12 months post procedure.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This study is for patients who require an aortic valve replacement due to severe aortic stenosis.
  • 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.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's 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 system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of...
  • 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 gain early clinical insight into the how the Intrepid transcatheter tricuspid valve replacement (TTVR) system device performs. There is a need for alternative and less invasive treatment options to treat this...