Clinical Trials

  • Principal Investigator:

    Robert J. Sommer, MD
    This is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety 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 with percutaneous, transcatheter PFO closure plus anti-platelet medical management compared to performance 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:

    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:

    Andrew J. Einstein, MD, PhD
    *COVID Cohort* We are seeking patients that have had a pre-COVID heart CT scan (Coronary Computed Tomography Angiography) that was performed at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital before March of 2020. For this study, half of patients will be required to have had COVID-19 symptoms (e.g., fever, cough, shortness of breath) and would have tested positive for COVID-19 (by an FDA-approved test). The other half will not have had a prior diagnosis of COVID-19. If you enroll in the study, you will be given a CT, asked to provide a blood sample as well as answer...
  • Principal Investigator:

    Andrew J. Einstein, MD, PhD
    *Non-COVID* We are seeking patients that have had a pre-COVID heart CT scan (Coronary Computed Tomography Angiography) that was performed at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital before March of 2020. For this study, half of patients will be required to have had COVID-19 symptoms (e.g., fever, cough, shortness of breath) and would have tested positive for COVID-19 (by an FDA-approved test). The other half will not have had a prior diagnosis of COVID-19. If you enroll in the study, you will be given a CT, asked to provide a blood sample as well as answer the...
  • Principal Investigator:

    Edward Felix Lin, MD
    The purpose of this study is to collect data about congestive heart failure over several months from patients at home and to assess the ability of a newly developed wireless device to accurately measure changes in the heart and lungs due to CHF. A secondary aim is to determine if the device may predict hospitalizations before they occur.
  • Principal Investigator:

    Sahil A. Parikh, MD
    The objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (calf) may have become blocked. To improve blood flow to the lower leg, the study doctor will open up this blockage using the Bare Temporary Spur Stent System.

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