Heart failure(HF) patients who are indicated for CRT-D device Heart Failure
Conditions
Interventions
Both MultiPole Pacing feature and CRT AutoAdapt feature ON
Sponsors
Kusano Kengo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient who has never received CRT 2. A patient who is eligible for CRT according to the guideline of The Japanese Circulation Society(JCS) and scheduled for implantation of CRT-D 3. A patient with a fixed residence who can follow the scheduled follow-up 4. A patient who has signed and dated the informed consent
Exclusion criteria
Exclusion criteria: 1. A patient who is suffering from AV block (excluding atrial conduction time 250 ms or more) 2. A patient who is suffering from chronic atrial fibrillation 3. A patient who underwent tricuspid valve surgery or has tricuspid cardiac surgery planned 4. A patients who has a life expectancy of less than 2 years with a non-cardiac cause 5. A patient who is pregnant, breastfeeding or may become pregnant 6. A patient who is less than 20 years of age at the time of consent 7. A patient who is already included or will enroll in another interventional study during this study 8. A patient who is judged by the Principal Investigator (PI) or the Sub-Investigator (SI) as ineligible for participation in this study due to another reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRT responder rate at 6 months after CRT-D implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Responder rate in 24 months 2. Change in cardiac function (LVEF, LVESV, LVEDV) by myocardial perfusion scintigraphy 3. Change in echocardiogram (LVEF, LVESV, LVEDV) 4. Survival rate and non-incidence rate of cardiovascular event 5. Change in NYHA Class 6. Change in QRS width on EKG 7. Change in serum brain natriuretic peptide(BNP) 8. Clinical composite score 9. Change in QOL questionnaire 10. New onset of atrial fibrillation | — |
Contacts
Public ContactYuko Inoue
National Cerebral and Cardiovascular Center
Outcome results
None listed