NCT05985408
Not Yet Recruiting
N/A
Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial
Fu Wai Hospital, Beijing, China1 site in 1 country40 target enrollmentSeptember 1, 2023
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Fu Wai Hospital, Beijing, China
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- left ventricular ejection fraction (LVEF)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.
Investigators
Li Xiaofei
Doctor
Fu Wai Hospital, Beijing, China
Eligibility Criteria
Inclusion Criteria
- •Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing;
- •Age between 18 and 90 years old;
- •The expected survival period is greater than 12 months;
- •Signed the informed consent form for the study.
Exclusion Criteria
- •Previous mechanical tricuspid valve replacement.
- •Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
- •Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
- •Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
- •Patients participated in any of the other studies at the same time, which may confound the results of this study.
- •Pregnancy, planning to become pregnant.
- •Patients with a history of heart transplantation.
Outcomes
Primary Outcomes
left ventricular ejection fraction (LVEF)
Time Frame: 12 months
LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular end-systolic volume (LVESV)
Time Frame: 12 months
LVESV evaluated by echocardiography
Secondary Outcomes
- NT-proBNP(12 months)
- paced QRSd duration.(12 months)
- 6-minute hall walk distance(12 months)
- All cause death(12 months)
- Heart failure rehospitalization(12 months)
- Rehospitalization for cardiovascular adverse events(12 months)
- Malignant ventricular arrhythmias(12 months)
Study Sites (1)
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