Clinical Trials

  • 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 transradial 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:

    Tamim M. Nazif, MD
    The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved in the United States by the Food and Drug Administration (FDA) in 2014, the procedure and valve iterations have become increasingly efficient with reducing complications. The EvolutTM PRO valves outer pericardial wrap has shown to enhance...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The study is assessing the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
  • Principal Investigator:

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

    Daichi Shimbo, MD
    The purpose of this clinical trial is to study the relationship of stress, salt excretion, and nighttime blood pressure. Blood pressure normally has a diurnal pattern: it is highest during the day and dips during the night. The effects of psychological stress can interfere with this normal pattern and cause elevated nighttime blood pressure or reduced blood pressure dipping. It is predicted that, in some individuals, psychological stress can interfere with the diurnal pattern of sodium excretion which, like blood pressure, is highest during the day and lowest at night. The purpose of this...
  • This study is trying to determine if using Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides the imaging support while directing the stent device via the artery in your groin or arm to the coronary artery. During the procedure iodine contrast fluid is repeatedly injected in your coronary arteries to visualize the coronary arteries on X-ray. This lasts only for a short...
  • Principal Investigator:

    Sahil A. Parikh, MD
    The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow can be restored. The balloon is then...
  • 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 hearts 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 evaluate the safety and performance of the EVOQUE Valve in patients with at least moderate tricuspid regurgitation and signs of, symptoms from or prior heart failure hospitalizations for tricuspid regurgitation...
  • Principal Investigator:

    Jeffrey W Moses, MD
    The purpose of this research study is to evaluate if it is safe and feasible to use the Impella Hemodynamic Platform to measure and display hemodynamic parameters (measurements of how much pressure the heart is generating and how much blood your heart is pumping) during PCI procedures. 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 Impella device will be placed via the a femoral artery and delivers up to 3.5 liters of blood per minute to the...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition where the blood draws back into the mitral valve causing the heart to pump harder. The population of patients are also those who are not eligible for conventional mitral valve surgery. For participants in this study population, the doctors...

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