Heart Failure
Conditions
Interventions
One cohort:CCM treats the heart failure patients with Non-responders of Cardiac Resynchronization Therapy for 7 years
0:40 patients with HF who fulfill the inclusion criteria will be enrolled. Baseline clinical and echocardiographic parameters while the patient is still receiving CRT therapy will be assessed.
0:An OPTIMIZER System will be implanted and patients will be evaluated at the following pre-determined time-points: 1 week, 3 months, 6 months and 12 months (Appendix I). After implantation of the Opt
0:After 1 year, patient will continue with long-term follow up and assessments according to standard clinical practice.
Sponsors
Impulse Dynamics
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Heart failure (HF) patients remain in New York Heart Association Class III or IV who have received cardiac resynchronization in form of biventricular pacemaker or biventricular cardiovertor-defibrillator devices; 2. Have been classified as non-responder of CRT as defined by absence of reduction of left ventricular end-systolic volume reduction of less than 15% after 3months of therapy; 3. Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, -blockers, etc.
Exclusion criteria
Exclusion criteria: 1. Subjects with severe symptomatic heart failure who would qualify for heart transplant, or who have recently (within 2 weeks) been hospitalized and treated with intravenous inotropic agents or intravenous diuretics or whose baseline VO2,max is known to be <10 ml O2/min/kg; 2. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease; 3. Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation; 4. Subjects without an ICD who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of OPTIMIZER III implantation; 5. Subjects who have an ICD who have had appropriate ICD firing during the past one month; 6. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring; 7. Subjects who have chronic atrial fibrillation or chronic atrial flutter; 8. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions); 9. Subjects who are unable to participate in a 6-minute walk; 10. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within three months or a PTCA procedure within one month of enrollment; 11. Subjects who have had a myocardial infarction within three months of enrollment; 12. Subjects who have mechanical tricuspid or aortic valves; 13. Subjects who have a prior heart transplant; 14. Subjects who are participating in another experimental protocol; 15. Subjects who are unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CCM will improve clinical and echocardiographic outcomes of the patient in CRT non-responders.; | — |
Countries
China
Contacts
Public ContactCheuk Man Yu / Sheung Poon
Outcome results
None listed