Heart Failure Heart Failure
Conditions
Interventions
Sponsors
Kusano Kengo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is 20 years of age or older at the time of consent acquisition 2. Subject who meets CRT indications according to the guidelines of the Japanese Circulation Society 3. Subject planning to implant CRT 4. Subject has signed and dated the informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject with a history of CRT implantation 2. Subject with severe heart failure that requires continuous administration of cardiotonic 3. Subject with unstable angina, acute myocardial infarction within 40 days, or within 3 months after coronary artery invasive treatment 4. Subject scheduled for tricuspid valve surgery 5. Pregnant woman 6. Subject participating in other clinical trials or intervention trials 7. Subject judged to be inappropriate to this study for other reasons by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate 6 months after implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of change in cardiac function by myocardial scintigraphy at 6 months after implantation (left ventricular ejection fraction: LVEF, left ventricular end systolic volume: LVESV, etc.) 2. Prognosis at 6 and 24 months after implantation (survival rate and cardiovascular event non-incidence rate) 3. Amount of change in NYHA at 6 and 24 months after implantation 4. Amount of change in serum natriuretic peptide levels at 6 and 24 months after implantation | — |
Contacts
Public ContactMaki Yurugi
National Cerebral and Cardiovascular Center Hospital
Outcome results
None listed