Assessment of Combined CCM and ICD Device in HFrEF

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 atleast 40 days post-MI, if an MI occurred;

8. Patient is willing to give informed consent, available for scheduled study follow-upvisits, and able to complete all testing described in the study protocol at theinvestigational 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 tostudy consent;

3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to studyconsent;

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 sametime (or within 30 days prior to study consent); Note: Registries and otherobservational studies are acceptable.

14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCMtherapy, as determined by Investigator.