Enrolling Clinical Trials

  • 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:

    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...
  • 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:

    Susheel Kumar Kodali, MD
    Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases 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) requires 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:

    Jeffrey W Moses, MD
    The purpose of this study is to demonstrate that the Impella Hemodynamic Platform (the StudyDevice) is safe and that measurements obtained are as good as currently used methods. This includes how much pressure the heart is generating and how much blood your heart is pumping during the PCI. 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 TheImpella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-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 is a research study 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 gain early clinical insight into 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...