INTEGRA-D: Assessment of Combined CCM and ICD Device in HFrEF
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CCM-D Implant The subject is implanted with the CCM-D device. |
Device: 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.
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Outcome Measures
Primary Outcome Measures
- Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) [Implant]
Evaluate the device effectiveness in converting induced VF at the time of implantation.
- Device-related Complications (Primary Safety Objective) [Implant to 6 months]
Evaluate device-related complications through 6-months (excluding lead-related complications).
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Inappropriate Shock Rate out to 2-years [Implant 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.
- Charging non-compliance [Implant to 2 years]
Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.
- Longitudinal levels of activity [Implant to 2 years]
Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.
- Battery degradation and longevity [Implant to 2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Individuals must meet all the following:
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Patient is aged 18 years or older;
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Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
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Patient has HFrEF (LVEF ≤40%);
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Patient is on GDMT for heart failure;
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Patient has a Class I or Class II indication for an ICD
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Patient has a reasonable expectation of meaningful survival of > 1 year;
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Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
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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.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
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Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
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Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
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Prior heart transplant or ventricular assist device;
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Implanted mechanical tricuspid valve;
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PR interval greater than 375ms or advanced AV block;
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In situ S-ICD, pacemaker, or CRT device;
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Indicated for CRT;
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End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
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Indicated for permanent bradyarrhythmia pacing;
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Unstable angina pectoris within 30 days prior to study consent;
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Pregnant or planning to become pregnant during the study;
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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.
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Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Impulse Dynamics
Investigators
- Principal Investigator: Niraj Varma, MD, PhD, The Cleveland Clinic
- Principal Investigator: Nir Uriel, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG_PRO_345