Chronic Heart Failure (CHF)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient has signed and dated study informed consent. Patient is able to receive pectoral implant. Patient is indicated for either CRT or CRT-D system; 2. Patient has moderate to severe HF (NYHA Class II, III or IV); 3. Patient has LVEF =120 ms; 5. Patient is in sinus rhythm.
Exclusion criteria
Exclusion criteria: 1. Patient has mechanical right heart valve (contraindicated for pacer wire placement); 2. Patient has experienced unstable angina, acute MI, CABG or PCI within the past 3 months; 3. Patient is on continuous or intermittent intravenous inotropic drug therapy; 4. Patient known to have chronic permanent atrial arrhythmias; 5. Patient is enrolled in any concurrent study that would confound the results of this study; 6. Patient has a life expectancy of less than 12 months; 7. Women who are pregnant, or with child-bearing potential and who are not on a form of birth control; 8. Patient with CRT device implanted previously. Patient has had a heart transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in LVES; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRT response rate;composite clinical response rate; | — |
Countries
China