LVSP Based CRT vs. RVAP Based CRT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure Cardiac Resynchronization Therapy Left Ventricular Septal Pacing Right Ventricular Septal Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LVSP-CRT

Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.

Group Type EXPERIMENTAL

left ventricular septal pacing

Intervention Type DEVICE

For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.

RVAP-CRT

Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.

Group Type ACTIVE_COMPARATOR

right ventricular apical pacing

Intervention Type DEVICE

For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.

Interventions

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left ventricular septal pacing

For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.

Intervention Type DEVICE

right ventricular apical pacing

For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.

Intervention Type DEVICE

Eligibility Criteria

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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.

8\. Patients with a history of heart transplantation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No