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Innovation in Healing Through Clinical Research

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Clinical research saves lives by granting patients access to medications, treatment methodologies, and technology before it is broadly available to the public. As part of our mission to consistently deliver the highest quality cardiovascular care, we are proud that our research team is able to bring our patients emerging, cutting-edge techniques and technology.

View Open Clinical Trials 

Deborah Heart and Lung Center’s Clinical Research department is involved in numerous trials — exploring and innovating new treatments and procedures in:

  • Electrophysiology
  • Interventional Cardiology
  • Heart Disease
  • Congestive Heart Failure
  • Vascular Disease
  • Cardiology

In addition to a team of highly-committed and talented Principal Investigators, the clinical research team at Deborah provides exceptional patient support through its research associates, who keep referring physicians and trial patients updated on their own progress as well as that of the clinical study as a whole.

Open Trials

  • PICANTE Trial – PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
    Focus:

    The study focuses on patients that will have a standard of care percutaneous coronary intervention (PCI) due to decrease heart pumping capacities. The purpose to obtain information about the safety and effectiveness of a new medical device, the KARDION Cory P4. The device is a pump placed in the heart during the coronary treatment procedure to assist blood flow through the heart.

    Principal Investigator: Muhammad Raza, M.D.
    Study Phase: Enrolling
    Description:

    The purpose of this trial is to demonstrate 30-day safety and effectiveness outcomes of the KARDION CORY P4 System (study device) in subjects who require hemodynamic support during PCI procedure.

    Device/Therapy Involved: Randomized treatment to one of the following devices: KARDION Cory P4 System - Percutaneous Mechanical Circulatory Support (study device) OR Impella - Percutaneous Mechanical Circulatory Support (commercial control)
    ClinicalTrials.gov: NCT06445608
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
    Focus:

    The purpose of this Research Study is to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System and compare it to standardized heart failure medications. The AccuCinch Ventricular Restoration System is an investigational (experimental) device intended to treat Research Subjects who are experiencing symptoms of heart failure due to a dilated left ventricle (heart chamber that pumps blood). Investigational means that the safety and effectiveness of the device is unknown.

    Principal Investigator: Muhammad Raza, M.D.
    Study Phase: Enrolling
    Description:

    The CORCINCH-HF Study is designed to evaluate the safety and efficacy of the AccuCinch® Ventricular Restoration System, a minimally invasive, transcatheter approach to treat the enlarged left ventricle. The AccuCinch System is designed to improve the structure and function of the heart and help bring relief to HF patients who remain symptomatic despite current guideline-directed medical care, including cardiac resynchronization therapy. These patients often have few options, such as implantation of a left ventricular assist device (LVAD), heart transplant, or palliative care.

    Device/Therapy Involved: AccuCinch Ventricular Restoration System vs Guideline-Directed Medical Therapy
    ClinicalTrials.gov: NCT04331769
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • The EMPOWER Trial: Assessment of the Carillon Mitral Contour System® in Treating Heart Failure with Functional Mitral Regurgitation
    Focus:

    The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

    Study Phase: Enrolling
    Description:

    Patients with heart failure often develop enlargement of their heart. This can cause the mitral valve to malfunction. When the enlargement of the heart causes the mitral valve to malfunction, this is called functional mitral regurgitation. The CARILLON Mitral Contour System is an investigational permanent implant developed for the treatment of functional mitral regurgitation (FMR). The implant is placed using a non-surgical (catheter-based) technique in the Coronary Sinus (CS), a vein on the outside of the heart which is adjacent to the mitral valve. This simple procedure is designed to reshape the mitral valve, reduce valve leakage and thus reduce FMR.

    Device/Therapy Involved: Carillon Mitral Contour System®
    ClinicalTrials.gov: NCT03142152
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • Evolut™ EXPAND TAVR II Pivotal Trial
    Focus:

    Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

    Principal Investigator: Muhammad Raza, M.D.
    Study Phase: Enrolling
    Description:

    Patients with severe, symptomatic AS often receive a minimally invasive procedure known as transcatheter aortic valve replacement (TAVR) to replace their aortic valve. But for the more than two million people in the U.S. living with moderate, symptomatic AS, TAVR is not included in current treatment guidelines. The Medtronic-sponsored EXPAND II Pivotal Trial will, for the first time, evaluate the safety and effectiveness of the company’s Evolut™ PRO+ and Evolut™ FX TAVR prosthetic valves in patients with moderate, symptomatic AS.

    Device/Therapy Involved: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
    ClinicalTrials.gov: NCT05149755
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016

Terms & Conditions

By participating in this quiz, or screening or health assessment, I recognize and accept all risks associated with it. I understand that the program will only screen for certain risk factors and does not constitute a complete physical exam. For the diagnosis of a medical problem, I must see a physician for a complete medical exam. I release Deborah Heart and Lung Center and any other organization(s) involved in this screening, and their employees and agents, from all liabilities, medical claims or expenses which may arise from my participation. Thank you for investing in your health by participating today.