J-HIS-CRT

JRCT ID: jRCT1052200052

Registered date:07/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 05/03/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): His-bundle pacing

Outcome(s)

• Primary Outcome: Responder rate 6 months after implantation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kusano Kengo
• Source(s) of Monetary Support: Intramural Research Fund (30-3-1)for Cardiovascular Diseases of National Cerebral and Cardiovascular Center Prospective Intervention Study Using the Existing Devices to Develop a New Therapeutic Guideline