Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

What is the Purpose of this Study?

The purpose of this study is to determine whether cardiac contractility modulation (CCM), a heart failure device therapy that improves contraction of the heart, will reduce cardiovascular mortality and heart failure hospitalizations in certain patients. Specifically, researchers will focus on patients with an ejection fraction (EF) greater than or equal to 40% and less than or equal to 60%. EF refers to the amount of blood being pumped out of the left ventricle each time it contracts. While the OPTIMIZER system (device used in this study that is designed to treat heart failure) is approved for use in HFrEF patients, it is considered investigational for patients with an ejection fraction greater than 45% in the US. The OPTIMIZER System includes the Optimizer Smart Mini implantable pulse generator (IPG) that generates the CCM signals and 2 electric wires that deliver the CCM therapy.

Eligibility

1. Signed and dated informed consent form;
2. Male or non-pregnant female, 18 years or older;
3. Diagnosed with symptomatic heart failure;
4. LVEF ≥40 and ≤60% (as assessed by echo core lab);

Inclusion Criteria:

1. Signed and dated informed consent form;
2. Male or non-pregnant female, 18 years or older;
3. Diagnosed with symptomatic heart failure;
4. LVEF ≥40 and ≤60% (as assessed by echo core lab);
5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table B in Section 9.2.6)
6. Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance.
Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.

Exclusion Criteria:

1. Resting ventricular rate \<50 or \>110 bpm;
2. Resting systolic blood pressure \<100 or ≥160 mmHg;
3. BMI greater than 46
4. Any severe valvular stenotic disease or any severe valvular regurgitation;
5. Mechanical tricuspid valve;
6. Complex congenital heart disease;
7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
9. A KCCQ CCS score higher than 85;
10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
13. Receiving cardiac resynchronization therapy (CRT);
14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
15. Myocardial infarction within 90 days prior to study consent;
16. Prior heart transplant or ventricular assist device;
17. Planning to become pregnant during the study;
18. Dialysis (permanent) or GFR \<20 ml/min/1.73m2;
19. Participating in another investigational study;
20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
21. Expected lifespan of less than 18 months from time of study consent;

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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 Implantable CCM in the Heart Failure Group with Higher Ejection FRaction

Study Details

Disease Type/Condition

Heart failure

Principal Investigator

Czer, Lawrence

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002123

ClinicalTrials.gov ID

NCT05064709

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org