What is the Purpose of this Study?
The purpose of this study is to determine whether an investigational device called the OPTIMIZER Integra CCM-D System can effectively defibrillate (send a controlled shock to restore normal rhythm) and treat episodes of ventricular tachycardia or ventricular fibrillation. Ventricular tachycardia is a fast, abnormal heart rhythm that starts in the heart’s lower chambers. Ventricular fibrillation is a type of arrhythmia, or irregular heartbeat, that affects the heart’s ventricles. The OPTIMIZER Integra CCM-D System is the combination of CCM (cardiac contractility modulation) and a new ICD (implantable cardioverter defibrillator) heart failure therapy. Participants in this study have a type of heart failure that may respond to a device-based therapy (CCM); they will receive the OPTIMIZER INTEGRA CCM-D System, which includes an implantable pulse generator that generates the CCM signals and 2 electric wires (leads) that will connect the heart to the IPG and deliver the CCM therapy and, if needed, the ICD therapy as well.
Eligibility
- Individuals must meet all the following:
- 1. Patient is aged 18 years or older;
- 2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
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Inclusion Criteria:
- Individuals must meet all the following:
- 1. Patient is aged 18 years or older;
- 2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
- 3. Patient has HFrEF (LVEF ≤40%);
- 4. Patient is on GDMT for heart failure;
- 5. Patient has a Class I or Class II indication for an ICD
- 6. Patient has a reasonable expectation of meaningful survival of \> 1 year;
- 7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
- 8. 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:
- 1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
- 2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
- 3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
- 4. Prior heart transplant or ventricular assist device;
- 5. Implanted mechanical tricuspid valve;
- 6. PR interval greater than 375ms or advanced AV block;
- 7. In situ S-ICD, pacemaker, or CRT device;
- 8. Indicated for CRT;
- 9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
- 10. Indicated for permanent bradyarrhythmia pacing;
- 11. Unstable angina pectoris within 30 days prior to study consent;
- 12. Pregnant or planning to become pregnant during the study;
- 13. 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.
- 14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
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