Assessment of Combined CCM and ICD Device in HFrEF
- Conditions
- Heart FailureHeart Failure With Reduced Ejection FractionImplantable Defibrillator UserCCM TherapyNon-ischemic CardiomyopathyIschemic CardiomyopathySudden Cardiac ArrestArrhythmias, CardiacVentricular TachycardiaVentricular Fibrillation
- Interventions
- Device: OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Registration Number
- NCT05855135
- Lead Sponsor
- Impulse Dynamics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
Individuals must meet all the following:
- Patient is aged 18 years or older;
- Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
- Patient has HFrEF (LVEF ≤40%);
- Patient is on GDMT for heart failure;
- Patient has a Class I or Class II indication for an ICD
- Patient has a reasonable expectation of meaningful survival of > 1 year;
- Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
- Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
An individual who meets any of the following criteria will be excluded from participation in this study:
- Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
- Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
- Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Implanted mechanical tricuspid valve;
- PR interval greater than 375ms or advanced AV block;
- In situ S-ICD, pacemaker, or CRT device;
- Indicated for CRT;
- End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
- Indicated for permanent bradyarrhythmia pacing;
- Unstable angina pectoris within 30 days prior to study consent;
- Pregnant or planning to become pregnant during the study;
- Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
- Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CCM-D Implant OPTIMIZER® Integra CCM-D System (Treatment Arm) The subject is implanted with the CCM-D device.
- Primary Outcome Measures
Name Time Method Device-related Complications (Primary Safety Objective) Implant to 6 months Evaluate device-related complications through 6-months (excluding lead-related complications).
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) Implant Evaluate the device effectiveness in converting induced VF at the time of implantation.
- Secondary Outcome Measures
Name Time Method Inappropriate Shock Rate out to 6-months (Secondary Safety Objective) Implant to 6 months Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.
Trial Locations
- Locations (61)
Phoenix Heart
🇺🇸Phoenix, Arizona, United States
CardioVascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
Chan Heart Rhythm Institute
🇺🇸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
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
Mount Sinai Medical Center Miami Beach
🇺🇸Miami Beach, Florida, United States
Baptist Health South Florida
🇺🇸Miami, Florida, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Cleveland Clinic Weston
🇺🇸Weston, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Ochsner Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Saint Luke's Mid America Heart Institute
🇺🇸Kansas City, Missouri, United States
St. Louis VA
🇺🇸Saint Louis, Missouri, United States
St. Louis Heart and Vascular
🇺🇸St. Louis, Missouri, United States
University of Nebraska Omaha
🇺🇸Omaha, Nebraska, 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
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States