Multi Point Pacing and Continuous Atrioventricular Conduction OPtimization of Cardiac Resynchronization Therapy: PPAP-CRT

JRCT ID: jRCTs052210081

Registered date:09/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure(HF) patients who are indicated for CRT-D device
• Date of first enrollment: 09/09/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Both MultiPole Pacing feature and CRT AutoAdapt feature ON

Outcome(s)

• Primary Outcome: CRT responder rate at 6 months after CRT-D implantation

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kusano Kengo
• Source(s) of Monetary Support: BIOTRONIK JAPAN.INC.