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NCT Number: NCT06023784

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100730, China

Location contact

Deyan Yang, PhD.

CONTACT

[email protected]

+86 (010)69155068

Taibo Chen, PhD.

CONTACT

+86 (010)69155068

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. the incidence of new-onset atrial fibrillation

    Time frame: within two years after device implantation

Secondary outcomes

  1. all-cause mortality

    Time frame: within two years after device implantation

  2. hospitalization for heart failure

    Time frame: within two years after device implantation

  3. an device upgrade for heart failure

    Time frame: within two years after device implantation

  4. alteration of quality of life score

    Time frame: within two years after device implantation

  5. Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography

    Time frame: within two years after device implantation

  6. pacemaker-associated cardiomyopathy

    Time frame: within two years after device implantation

Study contacts

Contact information is provided by the study sponsor or research team.

Deyan Yang, PhD.

CONTACT

[email protected]

+86 (010)69155068

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Sep 5, 2023
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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