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

NCT06023784 | Not Yet Recruiting

• 1 other identifier: the July study
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Left Bundle Branch Area Pacing; Right Ventricular Pacing; Atrioventricular Block; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• the incidence of new-onset atrial fibrillation

  within two years after device implantation

Secondary Outcomes (6)

• 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

Study Arms (2)

left bundle branch area pacing

EXPERIMENTAL

Procedure: left bundle branch area pacing

right ventricular pacing

ACTIVE COMPARATOR

Procedure: right ventricular pacing

Interventions

left bundle branch area pacing PROCEDURE

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.

left bundle branch area pacing

right ventricular pacing PROCEDURE

Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

right ventricular pacing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Atrioventricular Block; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Taibo Chen, PhD.

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Deyan Yang, PhD.

CONTACT

+86 (010)69155068; swallow_sums@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 5, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)