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

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.

Conditions

• Atrioventricular Block

Interventions

PROCEDURE

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).

PROCEDURE

Right ventricular pacing

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

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Zhongshan Hospital Xiamen University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Xijing Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Jiangang Zou · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-22

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• China

Study Locations