Skip to main content
Clinical Trials/NCT05883722
NCT05883722
Not yet recruiting
Not Applicable

Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

Xu Liu0 sites200 target enrollmentJune 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation, Persistent
Sponsor
Xu Liu
Enrollment
200
Primary Endpoint
Atrial fibrillation recurrence
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 30, 2023
End Date
December 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xu Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Xu Liu

Prof

Shanghai Chest Hospital

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;

Outcomes

Primary Outcomes

Atrial fibrillation recurrence

Time Frame: 12 months

any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.

Secondary Outcomes

  • Atrial fibrillation/atrial tachycardia recurrence(12 months)

Similar Trials