Assessment of Combined CCM and ICD Device in HFrEF (INTEGRA-D)

Impulse Dynamics

Status: Enrolling

Conditions: Heart Failure with Reduced Ejection Fraction; CCM Therapy; Arrhythmias, Cardiac; Implantable Defibrillator User; Ventricular Fibrillation; Sudden Cardiac Arrest; Heart Failure; Non-ischemic Cardiomyopathy; Ventricular Tachycardia; Ischemic Cardiomyopathy

Treatments: Device: OPTIMIZER® Integra CCM-D System (Treatment Arm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05855135

RG_PRO_345

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

CCM-D Implant

Experimental group

Description:

The subject is implanted with the CCM-D device.

Treatment:

Device: OPTIMIZER® Integra CCM-D System (Treatment Arm)