Circumferential Pulmonary Venous Isolation Combined With Bachmann Bundle Modification Versus Circumferential Pulmonary Venous Isolation for Persistent Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Northern Hospital

About this trial

This study is a prospective, randomized controlled, single-blind, multicenter study design. To evaluate the safety and efficacy of traditional pulmonary vein isolation (PVI) alone and PVI combined with Bachmann bundle ablation on persistent atrial fibrillation.

According to the treatment strategy, they were divided into two groups. Control group: circumferential PVI alone group (CPVI). Experimental group: CPVI combined with Bachmann bundle ablation group (CPVI-BBM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects≥ 18 years old and ≤ 75 years old;

the subject was diagnosed with persistent atrial fibrillation (duration of ≥6 months and ≤ 3 years);

Able to understand the purpose of the trial, voluntarily participate in this study, the subject or his legal representative signed the informed consent form, and was willing to complete the follow-up according to the requirements of the protocol.

Disqualifiers

Previous atrial fibrillation catheter ablation therapy, left atrial appendage closure or atrial fibrillation surgery;

atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible disease, or non-cardiac causes;

Left atrial or left atrial appendage thrombus (confirmed by esophageal ultrasound or CT examination);

Patients with pulmonary vein stenosis or pulmonary vein stents implanted;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional pulmonary vein isolation (PVI) ablation

    Procedure/Surgery

    Traditional pulmonary vein isolation (PVI) ablation

  • Bachmann bundle modification

    Procedure/Surgery

    Bachmann bundle modification

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: CPVI-BBMExperimental treatment 2 interventions
Group B: CPVIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sinus rhythm maintenance rate after ablation in the CPVI group and CPVI-BBM group at 1 year.

Time frame
1year

Secondary outcomes

1

Immediate success rate of surgery

Time frame
Intra-procedure
2

Direct termination rate of intraoperative atrial fibrillation

Time frame
Intra-procedure
3

The number of cardioversions

Time frame
Intra-procedure
4

Total operative time (defined as the total time from the first femoral venous puncture to the final catheter removal)

Time frame
Total operative time

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: