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    Clinical Research

    Clinical Research

    Overview of the Research Program at Eisenhower Desert Cardiology


    The physicians of Eisenhower Desert Cardiology (EDCC) have been actively involved in conducting clinical research since the mid 1990's. The program has grown exponentially since its inception and we are highly sought after as a research site by pharmaceutical, medical device and biotechnology companies. EDCC has also participated in several prestigious NIH-funded studies. Participation in research offers advantages to patients, physicians, and the community. Our cardiologists are knowledgeable of and able to offer the most cutting edge therapeutic and diagnostic treatment options.

    A number of the clinical staff at EDCC functions as coordinators for studies. Our Nurse-Practitioners, Physician Assistants, nurses from the Heart Failure clinic, and staff from clinical areas throughout the hospital have all participated in conducting trials. Eisenhower Desert Cardiology has a full-time Certified Clinical Research Professional - RN for the past 10 years, as well as an Assistant Coordinator. Every physician who participates as an Investigator is required to maintain a certification in the Protection of Human Subjects and have knowledge of Good Clinical Practice and the ICH guidelines.

    Our patients may be asked to participate in an ongoing study if their EDCC physician feels it is in their best interest and if the inclusion/ exclusion criteria for the study is met. Physicians and research staff are available to explain the study and provide answers to study questions anytime.
     
    All studies must be approved by the Institutional Review Board of Eisenhower Medial Center and follow HIPAA regulations for privacy. Participation is voluntary.

    Attached is a brief overview of some of the studies we are/have participated in over the last 5 years. It encompasses the broad range of cardiology, including the Electrophysiology Procedures, Cardiac Catheterization Procedures, Cardiac Medication, Heart failure, Nuclear Imaging and Health Data Registries.


    CURRENT RESEARCH STUDIES

    ProMRI
    Study to confirm MRI safety of Entovis pacemaker and Sertrox S Pacing Leads. In Phase A - study subjects will undergo MRI of brain and lumbar after leads are healed into place with a 1 and 3 month follow up. Phase B - study subjects will undergo a thoracic MRI with a 1 and 3 month follow up.
    Phase C will involve the Iforia ICD with Sertrox Smart and Linox Smart Leads. It will be a full body MRI inclusion zones of brain, thorax and lumbar, with a 1 and 3 month follow up.
          Principal Investigator: Leon A. Feldman, MD
          Sub-Investigator: Andrew M. Rubin, MD
          Sponsor: BIOTRONIK
    Enrollment Status: OPEN

    ORBIT AF II
    Registry for post-marketing surveillance data that is needed for assessing the safety of new anticoagulants when used in broader pt. populations and community practice settings.
         Principal Investigator: Philip J. Patel, MD
         Sponsor: JANSSEN PHARMACEUTICALS
    Enrollment Status: OPEN

    LSR of Acuity Spiral
    Evaluate long term reliability and clinical performance of Boston Scientific
    ACUITY Spiral Lead.  Evaluated by a chronic LV lead-related complication-free
    rate over 5 year follow up
         Principal Investigator:  Leon A. Feldman, MD
         Sub-Investigator:  Andrew M. Rubin, MD
         Sponsor:  BOSTON SCIENTIFIC
    Enrollment Status:  OPEN

    PSR - Product Surveillance Registry
    All studies integrated into the PPP provide ongoing information on the acute and chronic performance of Medtronic market-released cardiac therapy products
         Principal Investigator:  Andrew M. Rubin, MD
         Sub-Investigator:  Leon A. Feldman, MD
         Sponsor:  MEDTRONIC
    Enrollment Status:  OPEN

    CIRT - Cardiovascular Inflammation Reduction Trial
    To determine in a randomized, double-blind, placebo-controlled setting whether treatment with low dose methotrexate will reduce the rate of heat attack, stroke or cardiovascular death among patients with atherosclerosis.
          Principal Investigator: Philip J. Patel, MD
          Sponsor: NATIONAL HEART LUNG AND BLOOD INSTITUTE
    Enrollment Status: PENDING


    Current Research Studies Not Enrolling In Follow Up Only

    CELESTIAL
    Post-approval registry to confirm long-term safety and reliability of the Corox OTW BP LV lead as used in conjunction with any  BIOTRONIK CRT-D or CRT-P, from implant through 5 years
         Principal Investigator:  Leon A. Feldman, MD
         Sub-Investigator: Andrew M. Rubin, MD
         Sponsor: BIOTRONIK
    Enrollment Status:  FOLLOW UP

    GLORIA AF - PHASE II/III
    GLORIA-AF Phase II/III is part of a global, multi-center, prospective Registry Program investigating patients with newly diagnosed non-valvular AF at risk for stroke (defined as a CHA2DS2-VASc stroke risk score of at least 1)
         Principal Investigator:  Andrew M. Rubin, MD
         Sub-Investigator:  Leon A. Feldman, MD
         Sponsor:  BOEHRINGER-INGELHEIM
          
    Enrollment Status: FOLLOW UP


    Current Research Studies Not Enrolling

    INGEVITY
    IDE study to evaluate the safety, performance and effectiveness of the INGEVITY Active and Passive Fixation Pace/Sense Leads, 5 year follow up
          Principal Investigator: Andrew M. Rubin, MD
          Sub-Investigator: Leon A. Feldman, MD
          Sponsor: BOSTON SCIENTIFIC
    Enrollment Status: FOLLOW UP

    ORBIT II
    Pivotal study to evaluate the safety and performance of Orbital Atherectomy System in treating de novo, severely calcified coronary lesions.
         Principal Investigator:  Puneet K. Khanna, MD
         Sub-Investigators:  Barry T. Hackshaw, MD
                                      Khoi M. Le, MD
                                      Andrew D. Frutkin, MD
         Sponsor:  CARDIOVASCULAR SYSTEMS INC.
    Enrollment Status:  FOLLOW UP

    ACCENT MRI
    The intent of this IDE study is to evaluate the safety and efficacy of the implanted Accent MRITM system, which includes the investigational St. Jude Medical Tendril MRITM lead and Accent MRITM DR pacemaker, in and out of the MRI environment.
         Principal Investigator: Andrew M. Rubin, MD
         Sub-Investigator:  Leon A. Feldman, MD, Damon E. Kelsay, MD
         Sponsor: ST. JUDE
    Enrollment Status:  FOLLOW UP

    GALAXY
    Post market registry to confirm long term safety and reliability of BIOTRONIK ICD leads as used in conjunction with any BIOTRONIK ICD pulse generator.
         Principal Investigator:  Andrew M. Rubin, MD
         Sub-Investigator: Leon A. Feldman, MD
         Sponsor: BIOTRONIK
    Enrollment Status:  FOLLOW UP


    Recently Closed Research Studies

    ABSORB III RCT
    IDE Study to evaluate the safety and effectiveness of the Abbott Vascular Absorb Bioresorbable Vascular Scaffold System.  Patients are randomized to either the study scaffold or XIENCE stent. 5 year follow up
          Principal Investigator: Khoi M. Le, MD
          Sub-Investigators: Puneet K. Khanna, MD
                                      Andrew D. Frutkin, MD
                                      Barry T. Hackshaw, MD
          Sponsor: ABBOTT VASCULAR
    Enrollment Status: CLOSED

    CHOCOLATE BAR
    To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of Chocolate in achieving optimal percutaneous transluminal angioplasty (PTA) procedural outcomes and to assess potential longer-term clinical benefits.
          Principal Investigator:  Puneet K. Khanna, MD     
          Sub-Investigator:  Khoi M. Le, MD 
          Sponsor:  TRIREME MEDICAL, INC.
          
    Enrollment Status: CLOSED

    XIENCE V USA/DAPT
    Registry to evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings.  If no events in first year post stent deployment, pt to enter Dual Anti-Platelet Therapy sub-study.
         Principal Investigator:  Barry T. Hackshaw, MD
         Sub-Investigator:         Khoi M. Le, MD
                                           Puneet K. Khanna, MD
         Sponsor: ABBOTT VASCULAR
    Enrollment Status:  CLOSED

    EchoCRT
    Demonstrate whether Cardiac Resynchronization Therapy (CRT=ON) in heart failure patients with narrow QRS complex and echo evidence of ventricular dyssynchrony will significantly reduce the combined endpoint of all-cause mortality or first hospitalization for worsening heart failure when compared to CRT=OFF.
         Principal Investigator:  Leon A. Feldman, MD/Philip J. Patel, MD
         Sub-Investigator: Andrew M. Rubin, MD
         Sponsor: BIOTRONIK
    Enrollment Status: CLOSED

    ARISTOTLE STUDY
    Apixaban for Reduction In Stroke and Other Thromboembolic Events in Atrial Fibrillation.
         Primary Investigator:  Andrew M. Rubin, MD
         Sub-Investigator: Leon A. Feldman, MD
         Sponsor: BRISTOL MYERS SQUIBB
    Enrollment Status: CLOSED

    BRADYCARE
    Observational study to gain better understanding of how diagnostic capabilities in the Accent/Athem pacemakers are being utilized to manage patient care.
         Principal Investigator: Andrew M. Rubin, MD
         Sub-Investigator: Leon A. Feldman, MD
         Sponsor:  ST. JUDE MEDICAL
    Enrollment Status: CLOSED

    DEFINITIVE LE
    Study of SilverHawk device in the treatment of atherosclerotic femoropopliteal and tibial-peroneal arteries - peripheral vascular disease
         Principal Investigator:  Puneet K. Khanna, MD
         Sub-Investigator: Khoi M. Le, MD
         Sponsor: EV3
    Enrollment Status:  CLOSED

    MADIT - RIT
    To determine whether dual chamber ICD or CRT-D devices programmed with high-rate cutoff and/or long delay will be associated with fewer patients who experience inappropriate ATP or shock therapies when compared to standard programming during the first year of post-implant follow up of patients with indication of primary prevention device therapy.
         Principal Investigator:  Leon A. Feldman, MD
         Sub-Investigator:  Andrew M. Rubin, MD
         Sponsor:  UNIVERSITY OF ROCHESTER/BOSTON SCIENTIFIC
    Enrollment Status:  CLOSED