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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06023784
• Other study ID #: the July study
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Deyan Yang, PhD.
• Phone: +86 (010)69155068
• Email: swallow_sums[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 530
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of new-onset atrial fibrillation		within two years after device implantation
Secondary	all-cause mortality		within two years after device implantation
Secondary	hospitalization for heart failure		within two years after device implantation
Secondary	an device upgrade for heart failure		within two years after device implantation
Secondary	alteration of quality of life score		within two years after device implantation
Secondary	Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography		within two years after device implantation
Secondary	pacemaker-associated cardiomyopathy		within two years after device implantation