Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

• Sponsor: Xu Liu (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05883722
• Collaborator: The Third Xiangya Hospital of Central South University (Other), Yangpu District Central Hospital Affiliated to Tongji University (Other)
• Enrollment: 200
• Arms: 2
• Anticipated Duration (Months): 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation, Persistent	Procedure: Catheter ablation	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RA group The RA group received adjunctive right atrial ablation in addition to left side ablation.	Procedure: Catheter ablation; The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation
Active Comparator: Control group The control group received left side ablation only.	Procedure: Catheter ablation; The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Outcome Measures

Primary Outcome Measures

1. Atrial fibrillation recurrence [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 Outcome Measures

1. Atrial fibrillation/atrial tachycardia recurrence [12 months]

   any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xu Liu
• The Third Xiangya Hospital of Central South University
• Yangpu District Central Hospital Affiliated to Tongji University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xu Liu, Prof, Shanghai Chest Hospital
• ClinicalTrials.gov Identifier: NCT05883722
• Other Study ID Numbers: KS(Y)23218
• First Posted: Jun 1, 2023
• Last Update Posted: Jun 1, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Xu Liu, Prof, Shanghai Chest Hospital: catheter ablation; atrial fibrillation; Driver ablation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jun 1, 2023