heart failure wea
Conditions
Interventions
Subjects undergoing implantation of an OPTIMIZER pulse generator and associated
leads will be prepared for device implantation according to the procedure of
the institution. After access to the subc
Sponsors
Impulse Dynamics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a) Baseline ejection fraction * 25% and *45% (as assessed by the site) b) NYHA class II or III despite receiving optimal medical therapy for heart failure, stable for at least 30 days based on patient*s medical records (chronic, not transient, heart failure) c) Baseline VO2,max * 9 and * 18.5 ml O2/Kg/min
Exclusion criteria
Exclusion criteria: a) Potentially correctible cause of HF (valvular, congenital, or untreated ischemic heart disease) b) Clinically significant angina pectoris c) Hospitalization for HF requiring the use of inotropic support within 30 days of enrollment d) PR interval greater than 375 ms e) Permanent or long-standing persistent atrial fibrillation/flutter, or cardioversion within 30 days of enrollment. f) Exercise tolerance limited by condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or unable to perform baseline stress testing g) Scheduled for a CABG or a PTCA procedure, or CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment. h) Biventricular pacing system, or indication for Biventricular pacing system i) Myocardial infarction within 90 days of enrollment. j) Mechanical tricuspid or aortic valves. k) Ventricular assist device l) Prior heart transplant m) Pregnant or planning to become pregnant during the study n) Age below 18 o) Subject participating in another study, unrelated to CCM, at the same time (or within 30 days prior to enrollment to this study) p) Subjects on dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primarv endpoint: Comparison between the groups of change in V02 max from baseline to 24 weeks of follow-up. VO2max will be evaluated by cardiopulmonary stress test (CPX), in a double assessment (i.e., tests will be repeated twice at each study follow-up - the two evaluations can be up to 2 weeks apart). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondarv endpoints: Efficacv Comparison between the groups of: * Change in quality of life as measure by Minnesota Living With Heart Failure Questionnaire (MLWHFQ), from baseline to 24 weeks. * Change in NYHA class, from baseline to 24 weeks * Change in V02max from baseline to 24 weeks for each of the following subgroups separately: Baseline EF 35% Other endpoints - exoloratory: Change in SHFM and MAGGIC survival prediction model scores from baseline to 6 month of follow-up. Safetv endpoints: Comparison between the groups of: * All-cause mortality * Cardiovascular mortality * Time to first event - cardiovascular related (death, LVAD, urgent heart transplant or unplanned heart failure hospitalization) * Time to first event - all cause (death or unplanned hospitalization) | — |
Countries
Netherlands
Outcome results
None listed