Clinical Trials

  • Principal Investigator:

    Robert J. Sommer, MD
    The purpose of this study is to collect more information about the GORE CARDIOFORM Septal Occluders (GSO device) treatment to close the Patent Foramen Ovale (PFO) to reduce the risk for another stroke.
  • Principal Investigator:

    Ajay J. Kirtane, MD, SM
    RADIANCE II is a randomized, double-blind, sham-controlled, single cohort study designed todemonstrate the effectiveness (how well it works) and safety of the Paradise Renal Denervation System in hypertensive subjects (subjects with high blood pressure).
  • 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
    This is a prospective, multi-center open label first in human clinical study aimed at demonstrating safety and technical performance of the Cardiovalve device to minimize tricuspid regurgitation. Tricuspid regurgitation is a disorder in which the valve does not close tight enough. This problem causes blood to flow backward into the right upper heart chamber (atrium) when the right lower heart chamber (ventricle) contracts. The purpose is to evaluate the safety and technical performance of the Cardiovalve System to successfully treat patients with severe tricuspid regurgitation. The tricuspid...
  • 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:

    Dimitrios Karmpaliotis, MD
    A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are for the intended use of facilitating the safe and effective crossing of coronary arteries that are blocked and placement of conventional guidewires beyond the narrowed artery. The data captured in this study will be used to support U.S. Food...
  • 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 withsymptomatic 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:

    Sahil A. Parikh, MD
    This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the therapies that has been used to treat PAD is balloon angioplasty. It is a procedure where a small balloon is inserted into the blood vessel next to the area that is narrowed and inflated temporarily. The inflated balloon opens up the narrowing by pushing on the wall of the blood vessel to restore blood flow...
  • Principal Investigator:

    Amardeep S. Saluja, MD
    This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation.

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