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:

    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:

    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:

    Muredach Patrick Reilly, MD
    While the biobank can support research of many different diseases and conditions, we are focusing our research now on COVID-19. This research is being conducted to help to advance our understanding of the COVID-19 virus, including but not limited to: how the virus is spread, potential vaccines or other treatments, genetic susceptibility to severe disease, and other questions that will come up as we continue our research studies. CUB will facilitate this research by providing biological samples and medical information to Columbia-NYP researchers and our collaborators around the world who are...
  • 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).

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