Assessment of Combined CCM and ICD Device in HFrEF
Active, not recruiting · Not applicable · NCT05855135
Conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation
At a glance
- Research payments reported, 2025
- $701,173
- U.S. investigators named
- 56
- Sites paid
- 57
- Planned or actual enrollment
- 300
About the trial
- Sponsor
- Impulse Dynamics
- Tested
- OPTIMIZER® Integra CCM-D System (Treatment Arm) (device)
- Dates
- Started 2023-05-17; completion 2027-07
- Results posted
- Not yet
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the imp…
From ClinicalTrials.gov, last updated 2026-11-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Impulse Dynamics (USA) Inc. reported $701,173 in research payments for this study in 2025 (126 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Andrew J. Kaplan, M.D. Cardiology · Mesa, AZ
- Nathan Laufer, MD Cardiology · Phoenix, AZ
- Nareg Minaskeian, MD Cardiac Electrophysiology · Mesa, AZ
- Ambrose F. Panico, D.O. Cardiac Electrophysiology · Mesa, AZ
- Rahul N. Doshi, M.D. Cardiac Electrophysiology · Los Angeles, CA
- Michael Shehata, M.D. Cardiac Electrophysiology · West Hollywood, CA
- Christopher P. Porterfield, MD FACC Cardiac Electrophysiology · Aurora, CO
- Paras S. Bhatt, MD Cardiac Electrophysiology · Norwich, CT
- Ahmed F. Osman, MD Cardiac Electrophysiology · Fort Lauderdale, FL
- Mario I. Pascual, M.D. Cardiac Electrophysiology · Miami, FL
- Usman R. Siddiqui, MD Cardiac Electrophysiology · Winter Park, FL
- Raul Weiss, M.D. Cardiac Electrophysiology · Miami Beach, FL
- Jason Meyers, MD Cardiac Electrophysiology · West Des Moines, IA
- Rhea C. Pimentel, MD Cardiac Electrophysiology · Kansas City, KS
- Gery F. Tomassoni, M.D. Cardiac Electrophysiology · Lexington, KY
- Theofanie Mela, MD Cardiology · Boston, MA
- Imad Hussain, MD Cardiology · Rochester, MN
- Timothy J. Fendler, MD Heart Failure & Transplant Cardiology · Lees Summit, MO
- Nikhil C. Panda, MD Cardiac Electrophysiology · Saint Louis, MO
- Rafiq Ramadan, M.D. Interventional Cardiology · Saint Louis, MO
- Faisal F. Syed, MD Cardiac Electrophysiology · Sanford, NC
- Emad F. Aziz, D.O., M.B., CH.B. Cardiac Electrophysiology · Newark, NJ
- Raffaele Corbisiero, MD Cardiac Electrophysiology · Browns Mills, NJ
- Benjamin D'souza, MD Cardiac Electrophysiology · Cherry Hill, NJ
- Sameer Jamal, M.D. Cardiac Electrophysiology · Hackensack, NJ
- Heath E. Saltzman, M.D. Cardiac Electrophysiology · Cherry Hill, NJ
- Chirag R. Barbhaiya, MD Cardiac Electrophysiology · New York, NY
- James E. Ip, M.D. Cardiac Electrophysiology · New York, NY
- William Whang, MD Cardiology · New York, NY
- Hirad Yarmohammadi, M.D, M.P.H Cardiac Electrophysiology · New York, NY
- Sanjeeb S. Bhattacharya, M.D. Heart Failure & Transplant Cardiology · Cleveland, OH
- Varun Sundaram Cardiology · Cleveland, OH
- Ajay Vallakati, M.D. Heart Failure & Transplant Cardiology · Columbus, OH
- Ralph D. Ensley, M.D. Heart Failure & Transplant Cardiology · Tulsa, OK
- Peter Jessel, M.D. Cardiology · Portland, OR
- Sandeep Bansal, MD, MPH Cardiac Electrophysiology · Lancaster, PA
- Sheetal Chandhok, MD Cardiology · Bryn Mawr, PA
- John Costello, D.O. Cardiac Electrophysiology · Philadelphia, PA
- Edmond M. Cronin, MB BCH BAO MRCPI Cardiac Electrophysiology · Philadelphia, PA
- Sandeep Jain Cardiac Electrophysiology · Pittsburgh, PA
- George C. Shaw, MD Cardiac Electrophysiology · Pittsburgh, PA
- Steven M. Stevens, MD Cardiac Electrophysiology · Bethlehem, PA
- Rohit Mehta, MD Cardiac Electrophysiology · Florence, SC
- Chad C. Ward, M.D. Cardiac Electrophysiology · Clemson, SC
- Frank A. Mcgrew, MD Cardiology · Memphis, TN
- Hamid Afshar-kharaghan, MD Cardiac Electrophysiology · Houston, TX
- Robert C. Canby, M.D. Cardiac Electrophysiology · Austin, TX
- Kamala P. Tamirisa, MD Cardiac Electrophysiology · Dallas, TX
- Senthil K. Thambidorai, M.D. Cardiac Electrophysiology · Fort Worth, TX
- Stanislav Weiner, MD Cardiac Electrophysiology · Longview, TX
- Anju Bhardwaj, M.D. Heart Failure & Transplant Cardiology · Charlottesville, VA
- Guatham Kalahasty, MD Cardiology · Richmond, VA
- Guru P. Mohanty, M.D. Cardiac Electrophysiology · North Chesterfield, VA
- Matthew Sackett, MD Cardiac Electrophysiology · Lynchburg, VA
- Beixin J. He, MD, PHD Cardiac Electrophysiology · Seattle, WA
- John L. Mignone, MD, PHD Heart Failure & Transplant Cardiology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Strong Memorial Hospital, NY $132,589
- Phoenix Heart PLLC $71,605
- Seattle Institute for Biomedical and Clinical Research $62,762
- Rutgers the State University of Nj $59,121
- St Louis Heart & Vascular PC $50,530
- Arizona Cardiovascular Research Center $44,513
- Massachusetts General Hospital, MA $40,744
- Allegheny Singer Research Institute $29,205
- The Cleveland Clinic Educational Foundation $24,113
- Houston Methodist Hospital, TX $20,154
- Deborah Heart and Lung Center, NJ $17,900
- University of Kansas Medical Center $17,841
- Cardiovascular Associates of Mesa PC $14,541
- Mercyone Des Moines Medical Center, IA $12,825
- Honor Health John C. Lincoln Medical Center, AZ $8,958
- Ohio State University State Health System, OH $5,970
- Baptist Health Lexington, KY $5,940
- Houston VA Research and Education Foundation Inc $5,658
- NYU Grossman School of Medicine $5,455
- Adventhealth Orlando, FL $4,837
- Cedars-Sinai Medical Center, CA $4,665
- Saint Francis Hospital, Inc, OK $3,960
- Baptist Health South Florida $3,706
- Cleveland VA Medical Research and Education Foundation $3,633
- Sarah Cannon Research Institute $3,374
- Atrium Health $3,350
- Virginia Commonwealth University $3,230
- Medical City HCA Dallas $3,038
- Mount Sinai Medical Center of Florida, Inc, FL $2,900
- Southwest Cardiovascular Associates $2,693
- Cardiovascular Assoc Delaware Valley - Cadv $2,665
- Bryn Mawr Medical Specialists Association $2,373
- Hackensack University Medical Center, NJ $2,261
- Swedish Medical Center, WA $2,100
- Weill Medical College of Cornell Universiy $1,890
- St. Luke's Health Network, Inc. $1,743
- Hospital of Univ of Pennsylvania, PA $1,738
- St Lukes Hospital of Kansas City, MO $1,664
- The Trustees of Columbia University in The City of New York $1,593
- Centra Health - Lynchburg Gen Hospital, VA $1,214
- Christus Mother Frances Hospital, TX $1,205
- Temple University Hospital, PA $1,115
- Stern Cardiovascular Foundation Inc $1,110
- HCA Chippenham Hospital $1,050
- Icahn School of Medicine Mt. Sinai $945
- University of Pittsburgh Physicians $910
- Lancaster General Hospital, PA $890
- Virtua Our Lady of Lourdes Hospital, NJ $792
- Hartford Hospital, CT $586
- Broward Health Medical Center, FL $585
- Prisma Health Oconee Memorial Hospital, SC $559
- Texas Cardiac Arrhythmia Research Foundation $500
- Harris County Psychiatric Center, TX $455
- The University of North Carolina at Chapel Hill $448
- Medical City Fort Worth, TX $371
- Veterans Research Education Foundation of St. Louis $306
- HCA Medical Center of Aurora $300
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.