Clinical Trials

  • Principal Investigator:

    Tamim M. Nazif, MD
    This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from cows to direct the flow of blood through the heart the way a normal valve would if it was healthy. This artificial valve is delivered into the heart by a small flexible tube (catheter) that is about as big around as a pencil. This flexible...
  • Principal Investigator:

    Sahil A. Parikh, MD
    This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore blood flow) and whether that delivery helps to prevent re-narrowing of the blood vessel. If you are 18 and have a narrowing or blockage of the blood vessels (arteries) in your leg which your physician has determined needs to be treated with...
  • Principal Investigator:

    Ajay J. Kirtane, MD, SM
    This is a prospective, multi-center, single-arm, phased clinical study intended to provide pivotal data for device approval. The study is intended to demonstrate that the device, the SoundBite Crossing System Coronary can allow the passage of devices intended to treat a Chronic total occlusion (CTO). When arteries that supply blood to the heart become completely blocked, they are referred to as Chronic total occlusion (CTO). Although most blockages in the heart vessels can be opened by interventional cardiologists using minimally invasive techniques, opening completely blocked vessels remains...
  • Principal Investigator:

    Nir Uriel, MD, MSc
    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:

    Daichi Shimbo, MD
    We are conducting a research study in adults to test whether blood pressure (BP) measured in a clinic setting without a technician present is comparable to blood pressure levels while awake outside of the clinic on an Ambulatory Blood Pressure Monitoring (ABPM) device. We will also test whether asleep blood pressure can be accurately determined using a home blood pressure monitoring device, called HBPM. Eligible participants include English or Spanish-speaking adults who don't have cardiovascular disease and are NOT currently taking a blood pressure lowering medication. Study participation...
  • 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:

    Robert J. Sommer, MD
    This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This is a research study to evaluate the use of a device to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis. This is an international, multicenter, randomized, open-label, clinical trial comparing the safety and effectiveness of TAVR(Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 THV (transcatheter heart valve) and medical therapy to medical therapy alone in HF patients with moderate AS. You will...
  • 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.

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