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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCM-D Implant | Experimental | The subject is implanted with the CCM-D device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTIMIZER® Integra CCM-D System (Treatment Arm) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) | Evaluate the device effectiveness in converting induced VF at the time of implantation. | Implant |
| Device-related Complications (Primary Safety Objective) | Evaluate device-related complications through 6-months (excluding lead-related complications). | Implant to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate Shock Rate out to 6-months (Secondary Safety Objective) | Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit. | Implant to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inappropriate Shock Rate out to 2-years | Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur. | Implant to 2 years |
Inclusion Criteria:
Individuals must meet all the following:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Niraj Varma, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Nir Uriel, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Heart | Glendale | Arizona | 85306 | United States | ||
| CardioVascular Associates of Mesa |
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Single arm, prospective, multicenter study of 300 subjects that will establish that the device can appropriately sense and convert episodes of induced VF "on the table" in the implant procedure room, spontaneous episodes of VT/VF that occur during the study follow-up period, and ensure that the inappropriate shock rate is not unacceptably high.
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|
| Charging non-compliance |
Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject. |
| Implant to 2 years |
| Longitudinal levels of activity | Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends. | Implant to 2 years |
| Battery degradation and longevity | Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity. | Implant to 2 years |
| Compare worsening heart failure events pre- and post-implant | Track unscheduled cardiovascular-related healthcare encounters from 12 months prior to implant, if available, to 12 months post-implant | 12 months prior to implant and 12 months post-implant |
| All-cause mortality | Assess all-cause mortality using Seattle Heart Failure Model (SHFM) and comorbidity burden as a predictive comparator at 1 year and 2 years post-implant | 1 and 2 years post-implant |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Compare change in subject's perception of their heart failure symptoms, as measured by KCCQ, from baseline to 6 months. | Baseline to 6-months |
| EQ-5D-5L | Compare change in subject's perception of their health status, as measured by the EQ-5D-5L, from baseline to 6 months. | Baseline to 6-months |
| Six Minute Walk Distance (6MWD) | Compare change in functional capacity, as measured by 6MWD, from baseline to 6 months. | Baseline to 6 months |
| Mesa |
| Arizona |
| 85206 |
| United States |
| Southwest Cardiovascular Associates | Mesa | Arizona | 85208 | United States |
| Arizona Heart Rhythm | Phoenix | Arizona | 85016 | United States |
| CVC Cardiovascular Consultants | Phoenix | Arizona | 85032 | United States |
| Phoenix Heart | Phoenix | Arizona | 85306 | United States |
| Honor Health | Scottsdale | Arizona | 85258 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Hartford HealthCare | Hartford | Connecticut | 06102 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Baptist Health South Florida | Miami | Florida | 33173 | United States |
| Mount Sinai Medical Center Miami Beach | Miami Beach | Florida | 33140 | United States |
| Advent Health Orlando | Orlando | Florida | 32803 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| St. Louis VA | St Louis | Missouri | 63106 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Virtua | Cherry Hill | New Jersey | 08034 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| The Heart House - Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | 08035 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| Mount Sinai New York | New York | New York | 10029 | United States |
| Columbia University Medical Center / NewYork-Presbyterian | New York | New York | 10032 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28277 | United States |
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| St. Francis Tulsa | Tulsa | Oklahoma | 74136 | United States |
| Portland VA Medical Center | Portland | Oregon | 97239 | United States |
| St. Luke's Bethlehem | Bethlehem | Pennsylvania | 18015 | United States |
| Bryn Mawr Medical Specialists Association | Bryn Mawr | Pennsylvania | 19010 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Penn Presbyterian | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| Prisma Health | Greenville | South Carolina | 29601 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Medical City Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Medical City Fort Worth | Fort Worth | Texas | 76104 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Houston VA Hospital | Houston | Texas | 77030 | United States |
| UT Memorial Hermann | Houston | Texas | 77030 | United States |
| Christus Trinity Clinic | Tyler | Texas | 75702 | United States |
| Centra Health | Lynchburg | Virginia | 24501 | United States |
| Chippenham Hospital | Richmond | Virginia | 23225 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Seattle VA | Seattle | Washington | 98108 | United States |
| Swedish | Seattle | Washington | 98122 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D016757 | Death, Sudden, Cardiac |
| D001145 | Arrhythmias, Cardiac |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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