Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure

• Status: Terminated
• Trial end date: 2018-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to substantiate the efficacy of Cardiac Contractility Modulation (CCM) in the heart failure population with ejection fraction ranging between 25 and 45%. The study is designed in an adaptive manner to ensure proper statistical significance and power of the primary efficacy evaluation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Impulse Dynamics
• Treatments: Angiotensin Receptor Antagonists; Mineralocorticoid Receptor Antagonists; Mineralocorticoids

Criteria

Inclusion Criteria:

• Baseline ejection fraction ≥ 25% and ≤45% (as assessed by the site)

• NYHA class II or III (chronic, not transient, heart failure) despite receiving optimal medical therapy for heart failure

• Stable medication for heart failure for at least 30 days based on patient's medical records

• Baseline Peak VO2 ≥ 10 and ≤ 18.5 ml O2/Kg/min (as assessed by the site)

Exclusion Criteria:

• Potentially correctible cause of HF (valvular, congenital, or untreated ischemic heart disease)

• Clinically significant angina pectoris

• Hospitalization for HF requiring the use of inotropic support or IV diuretics within 30 days of enrollment

• PR interval greater than 375 ms

• Permanent or persistent atrial fibrillation/flutter or cardioversion within 30 days of enrollment.

• Exercise tolerance limited by condition other than heart failure (e.g., angina, chronic obstructive pulmonary disease (COPD), peripheral vascular disease, orthopedic or rheumatologic conditions) or unable to perform baseline stress testing

• Scheduled for a coronary artery bypass graft (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.

• Biventricular pacing system, or indication for Biventricular pacing system

• Myocardial infarction within 90 days of enrollment.

• Mechanical tricuspid or aortic valves.

• Ventricular assist device

• Prior heart transplant

• Pregnant or planning to become pregnant during the study

• Age below 18

• Subject participating in another study, unrelated to CCM, at the same time (or within 30 days prior to enrollment to this study)

• Subjects on dialysis