Clinical Trials

  • Principal Investigator:

    Kelly Marie Axsom, MD
    The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will utilize the market-released Reveal LINQ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 300 subjects at up to 30 sites in the US and will characterize the safety of the patient...
  • 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
    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 open-heart surgery) and may be...
  • Principal Investigator:

    Muredach Patrick Reilly, MD
    As an academic medical center, we are always working to improve patient and population health. One way that research is supported here is through the Columbia University Biobank (CUB). A biobank is a collection of biological samples and health data that is collected during a patient's medical care. The goal of a biobank is to provide materials for researchers to use in their scientific studies of health conditions such as cancer, heart disease, and diabetes. People who participate in a biobank help researchers find treatments and cures, and they also help their community benefit from improved...
  • 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:

    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 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
    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:

    Sanjum Sethi, MD
    This is a prospective, multi-center, observational, post-market study that will evaluate the safety and procedural success of performing trans-radial 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:

    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...

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