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Assessment of Combined CCM and ICD Device in HFrEF
Sponsor: Impulse Dynamics
Summary
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 implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2023-05-17
Completion Date
2027-07
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
OPTIMIZER® Integra CCM-D System (Treatment Arm)
The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.
Locations (59)
Phoenix Heart
Glendale, Arizona, United States
CardioVascular Associates of Mesa
Mesa, Arizona, United States
Southwest Cardiovascular Associates
Mesa, Arizona, United States
Arizona Heart Rhythm
Phoenix, Arizona, United States
CVC Cardiovascular Consultants
Phoenix, Arizona, United States
Phoenix Heart
Phoenix, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Hartford HealthCare
Hartford, Connecticut, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Mount Sinai Medical Center Miami Beach
Miami Beach, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Cleveland Clinic Weston
Weston, Florida, United States
Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
St. Louis VA
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Virtua
Cherry Hill, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Heart House - Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
NYU Langone
New York, New York, United States
Mount Sinai New York
New York, New York, United States
Columbia University Medical Center / NewYork-Presbyterian
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
St. Francis Tulsa
Tulsa, Oklahoma, United States
Portland VA Medical Center
Portland, Oregon, United States
St. Luke's Bethlehem
Bethlehem, Pennsylvania, United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Penn Presbyterian
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Medical City Dallas
Dallas, Texas, United States
UT Southwestern
Dallas, Texas, United States
Medical City Fort Worth
Fort Worth, Texas, United States
Houston Methodist
Houston, Texas, United States
Houston VA Hospital
Houston, Texas, United States
Christus Trinity Clinic
Tyler, Texas, United States
Centra Health
Lynchburg, Virginia, United States
Chippenham Hospital
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle VA
Seattle, Washington, United States
Swedish
Seattle, Washington, United States