LVSP Based CRT vs. RVAP Based CRT

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Right Ventricular Septal Pacing; Left Ventricular Septal Pacing; Cardiac Resynchronization Therapy
• Interventions: Device: left ventricular septal pacing; Device: right ventricular apical pacing

• Registration Number: NCT05985408
• Lead Sponsor: Fu Wai Hospital, Beijing, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14
• Study Start: 2023-09-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.

Exclusion Criteria

1. Previous mechanical tricuspid valve replacement.

2. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.

3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.

4. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.

5. Patients participated in any of the other studies at the same time, which may confound the results of this study.

6. Pregnancy, planning to become pregnant.

7. Patients with a history of heart transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LVSP-CRT	left ventricular septal pacing	Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.
RVAP-CRT	right ventricular apical pacing	Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.

Primary Outcome Measures

Name	Time	Method
left ventricular ejection fraction (LVEF)	12 months	LVEF evaluated by echocardiography，Bi-plane Simpson's method
left ventricular end-systolic volume (LVESV)	12 months	LVESV evaluated by echocardiography

Secondary Outcome Measures

Name	Time	Method
paced QRSd duration.	12 months	QRS duration measurement after the procedure
6-minute hall walk distance	12 months	6-minute hall walk distance
All cause death	12 months	All cause death events
Heart failure rehospitalization	12 months	Rehospitalization due to the exacerbation of heart failure
Rehospitalization for cardiovascular adverse events	12 months	Rehospitalization for cardiovascular adverse events
Malignant ventricular arrhythmias	12 months	ICD therapy for ventricular tachycardia or ventricular fibrillation
NT-proBNP	12 months	Serum NT-proBNP level

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China