Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

NCT ID: NCT05883722

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-12-30

Brief Summary

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Detailed Description

Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

Conditions

Atrial Fibrillation, Persistent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RA group

The RA group received adjunctive right atrial ablation in addition to left side ablation.

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Control group

The control group received left side ablation only.

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Interventions

Catheter ablation

The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;
• Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

Exclusion Criteria

• Uncontrolled congestive heart failure;
• History of severe valve disease and/or prosthetic valve replacement;
• Myocardial infarction or stroke within 6 months;
• Severe congenital heart disease;
• EF <40%;
• Contrast agent allergy;
• The use of anticoagulant drugs is contraindicated;
• Severe lung disease;
• Left atrial thrombus confirmed by preoperative esophageal ultrasound;
• Contraindications for cardiac catheterization;
• Atrial fibrillation ablation;
• Have performed any cardiac surgery within 2 months;
• Poor general health;
• Life expectancy < 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Yangpu District Central Hospital Affiliated to Tongji University

OTHER

Sponsor Role: collaborator

Xu Liu

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

KS(Y)23218

Identifier Type: -

Identifier Source: org_study_id