Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure (NCT02857309) | Clinical Trial Compass
TerminatedNot Applicable
Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure
Stopped: Slow enrolment.
Austria, Germany50 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pregn…
What they're measuring
1
Comparison between the groups of the change in Peak VO2 from baseline to 24 weeks of follow-up.