The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block

The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial

This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Atrioventricular Block; Left Bundle Branch Area Pacing; Right Ventricular Pacing
• Intervention / Treatment: Procedure: left bundle branch area pacing; Procedure: right ventricular pacing

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deyan Yang, PhD.; Phone Number: +86 (010)69155068; Email: swallow_sums@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
      • Contact: Deyan Yang, PhD.; Phone Number: +86 (010)69155068; Email: swallow_sums@163.com
      • Contact: Taibo Chen, PhD.; Phone Number: +86 (010)69155068

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18-85;
• AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms;
• Signed informed consent;

Exclusion Criteria:

• Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
• Patients with the history of atrial fibrillation;
• Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
• Pacemaker replacement without new implanted ventricular electrodes;
• Surgery is required within 1 year due to severe structural heart disease;
• Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);
• AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: left bundle branch area pacing	Procedure: left bundle branch area pacing; Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
Active Comparator: right ventricular pacing	Procedure: right ventricular pacing; Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of new-onset atrial fibrillation	within two years after device implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	within two years after device implantation
hospitalization for heart failure	within two years after device implantation
an device upgrade for heart failure	within two years after device implantation
alteration of quality of life score	within two years after device implantation
Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography	within two years after device implantation
pacemaker-associated cardiomyopathy	within two years after device implantation

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Taibo Chen, PhD., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Atrial Fibrillation; Atrioventricular Block
• Other Study ID Numbers: the July study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No