Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Heart Failure

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 ;

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

Study Details

Disease Type/Condition

Other

Principal Investigator

Shehata, Michael

Co-Investigators

Ashkan Ehdaie

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002516

ClinicalTrials.gov ID

NCT05855135

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org