Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Chris Azzam
cazzam@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Impulse Dynamics

Study Contact

Elizabeth Shaji
(856) 434-7957
eshaji@impulsedynamics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.