Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block

NCT04624763 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Not applicable

Started

2021-06-22

Last updated

2026-05-14

Condition(s) studied

Atrioventricular Block

Investigational drug(s) / intervention(s)

Left bundle branch pacingRight ventricular pacing

Left bundle branch pacing: LBBP is defined if fulfilling criterion 1 and at least one in criteria 2: 1. Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs); 2. One of the following should be met: 1. Selective LBBP with an iso-electrical window between the pacing spike and QRS onset; 2. If using dual-lead method with one at His-bundle and the other at LBB region, a retrograde His-bundle potential is recorded from His-bundle lead during LBBP; 3. LVATs at lead tip pacing of 1.5V/0.5ms and 10V/0.5ms are ≤ 80ms and the difference is \< 10ms; 4. A discrete LBB potential is recorded from lead tip and LVAT at tip pacing of 3V/0.5ms is ≤ 80ms19. If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP).

Right ventricular pacing: Implantation of a RV pacing lead is attempted using the standard-of-care technique first.

Study summary

OptimPacing study has been designed as a prospective, multi-center, randomized, controlled trial. A total of 11 medical centers across China will enroll 683 patients over an estimated recruitment period of 2 years. An LBBP group will be compared with a group of conventional RVP in the follow-up of at least 3 years. The study aimed to demonstrate (1) the superiority of LBBP in preserving LV systolic function over RVP and (2) the feasibility and long-term safety of LBBP in patients with AV block.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms 2. LVEF \> 35%, NYHA classification I-III 3. Age \> 18 years 4. Signed informed consent Exclusion Criteria: 1. Implanted prosthetic tricuspid valve 2. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months 3. Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months 4. Enrolled in any other study 5. A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons 6. Pregnant or with a child-bearing plan 7. A history of heart transplantation 8. Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect 9. Ventricular septal hypertrophy (≥ 15mm during diastole) 10. Isolated persistent left superior vena cava 11. With ICD, CRT or CRTD indications 12. Pacemaker replacement, upgrade and pocket infection needing re-implantation

Primary outcome measure(s)

A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM) — 6-month follow-up
Incidence of all-cause death, hospitalization for HF and/or PICM
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM) — 12-month follow-up
Incidence of all-cause death, hospitalization for HF and/or PICM
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM) — 24-month follow-up
Incidence of all-cause death, hospitalization for HF and/or PICM
A combined clinical endpoint of all-cause mortality, hospitalization for heart failure(HF) and/or occurrence of pacing-induced cardiomyopathy(PICM) — 36-month follow-up
Incidence of all-cause death, hospitalization for HF and/or PICM

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04624763 on ClinicalTrials.gov ↗ ← All trials in China