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Not yet recruiting NCT06023784

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

No phase Interventional Left Bundle Branch Area Pacing Right Ventricular Pacing Atrioventricular Block Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: left bundle branch area pacing, right ventricular pacing.
Who it may be relevant to
Registry conditions: Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • the incidence of new-onset atrial fibrillation [Time frame: within two years after device implantation]
Secondary outcome measures (6)
  • all-cause mortality [Time frame: within two years after device implantation]
  • hospitalization for heart failure [Time frame: within two years after device implantation]
  • an device upgrade for heart failure [Time frame: within two years after device implantation]
  • alteration of quality of life score [Time frame: within two years after device implantation]
  • Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography [Time frame: within two years after device implantation]
  • pacemaker-associated cardiomyopathy [Time frame: within two years after device implantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical C — Beijing

Identifiers

NCT: NCT06023784 · the July study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗