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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPeking Union Medical College Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • left bundle branch area pacing

    Procedure/Surgery

    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/Surgery

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

Treatment groups

530 Participants
are divided into 2 treatment groups
Group A: left bundle branch area pacingExperimental treatment 1 intervention
Group B: right ventricular pacingActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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