Skip to main content

Innovation in Healing Through Clinical Research

Male Doctor Meets With Female Patient

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.

For more information on clinical trials, please contact Andrew McElvarr at 609-893-1200, ext. 5016 or [email protected].

Open Trials

  • The THOR IDE Study
    Focus:

    The goal of this clinical trial is to test the Thor system in adult (≥ 18 year-old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD). The main questions it aims to answer are — is the Thor system safe in treating these lesions and does the Thor system work to treat these lesions? Participants will receive treatment with the Thor system and have follow-up visits at Discharge, 30 days, 6 months, and 12 months.

    Principal Investigator: Richard Kovach, MD
    Study Phase: Enrolling
    Description:

    Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

    All patients in the study will have treatment with the Thor system. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

    Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs.

    Device/Therapy Involved: All patients in the study will have treatment with the Thor laser atherectomy system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study.
    ClinicalTrials.gov: NCT05916950
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • MAGICAL BTK: Randomized Controlled Trial of MAGICTouch – Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
    Focus:

    Peripheral arterial disease (PAD) affecting the arteries in the lower leg and foot

    Standard of care below-the-knee percutaneous transluminal angioplasty (BTK PTA) is a minimally invasive procedure performed to treat peripheral arterial disease (PAD) affecting the arteries in the lower leg and foot. It aims to improve blood flow to these critical areas, alleviate symptoms, and promote wound healing in patients with conditions like critical limb ischemia (CLI) a condition that can cause pain, numbness, and sores that don't heal or claudication a condition that causes pain or cramping in the legs when walking or exercising.

    Principal Investigator: Richard Kovach, MD
    Study Phase: Enrolling
    Description:

    The purpose of this research study is to find out if a new investigational balloon device is effective in treating insufficient blood flow in the legs (also called peripheral arterial disease, PAD). This new balloon device, Magic Touch PTATM, is covered with sirolimus and is able to deliver the sirolimus drug to your blood vessels. We hope to learn if the use of a sirolimus coated angioplasty balloon will improve the treatment of insufficient blood flow in the leg.”

    Device/Therapy Involved: Randomly assigned to receive for the angioplasty procedure either: Sirolimus drug-coated balloon (investigational) or Placebo or standard PTA balloon
    ClinicalTrials.gov: NCT06182397
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • Integra-D Trial: Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects with Heart Failure and Reduced Ejection Fraction
    Focus:

    Heart failure with reduced ejection fraction

    The OPTIMIZER INTEGRA CCM-D System, also known as a “Cardiac Contractility Modulation – Defibrillator” is an investigational device system that combines CCM therapy and ICD therapy into one device. CCM therapy could effectively treat heart failure, and an ICD device could save a life if you are at risk for sudden cardiac arrest. This research study is designed to determine if the combination of CCM and ICD, as an investigational device can effectively defibrillate and treat episodes of ventricular tachycardia (VT) / ventricular fibrillation (VF) should any occur.

    Principal Investigator: Raffaele Corbisiero, MD
    Study Phase: Enrolling
    Description:

    The purpose of this trial is to demonstrate an implantable cardiac device system that combines cardiac contractility modulation, also known as CCM, and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a “Cardiac Contractility Modulation – Defibrillator.”

    Device/Therapy Involved: OPTIMIZER INTEGRA CCM-D System
    ClinicalTrials.gov: NCT05855135
    Trial Contact: Andrew McElvarr, 609-893-1200 ext. 5016
  • 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
  • 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.