Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Xu Liu

Status: Not yet enrolling

Conditions: Atrial Fibrillation, Persistent

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05883722

KS(Y)23218

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

RA group

Experimental group

Description:

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

Treatment:

Procedure: Catheter ablation

Control group

Active Comparator group

Description:

The control group received left side ablation only.

Treatment:

Procedure: Catheter ablation