Clinical Trials

  • Principal Investigator:

    Hirad Yarmohammadi, MD, MPH
    We are doing this study to gather information on participants returning at time of Cardiovascular Implantable Electronic Device (CIED) change-out or revision who underwent a device implantation with either a CanGaroo envelope, Tyrx envelope, or no envelope. A CIED is a device implantable inside the body, able to conduct pacing of the heart and therefore capable of correcting most life-threatening abnormal heart rhythms. People who have had surgery to implant a medical device that helps their heart, may have had their surgery done in slightly different ways. In this study, the investigators...
  • Principal Investigator:

    Frederick Arthur Ehlert, MD
    The purpose of this registry is to collect information over time about how Medtronic products are working and/or the outcome of the treatment. The registry will be used to support post-market surveillance/monitoring activities and post-approval studies (e.g., to collect safety and performanceinformation). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines and patient services/solutions. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,...
  • Principal Investigator:

    Susheel Kumar Kodali, MD
    The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment of mitral regurgitation. The device is designed to mimic a widely used surgical intervention with a percutaneous therapy. As such, it potentially offers a less invasive and safer treatment for mitral regurgitation in comparison to surgery...
  • 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:

    Amirali Masoumi, MD
    The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).
  • 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...
  • Principal Investigator:

    Dimitrios Karmpaliotis, MD
    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...

Pages