Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation

• Registration Number: NCT07122336
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

The design of this study is an intervention, randomized, controlled study and contains three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-16
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

1. Age ≥18 years
2. First-time ablation for persistent atrial fibrillation (PsAF)
3. Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
4. Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
5. Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
6. Ability and willingness to provide written informed consent
7. Compliance with all study follow-up requirements

Exclusion Criteria

1. Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
2. Long-standing persistent AF: Continuous AF duration >3 years
3. No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
4. Contraindications to systemic anticoagulation
5. Pregnancy
6. Advanced renal or hepatic failure
7. Severe valvular heart disease or cyanotic congenital heart disease
8. Hypertrophic cardiomyopathy (HCM)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat	12 months

Secondary Outcome Measures

Name	Time	Method
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months	12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure	12 months
The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs.	12 months
Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs)	12 months
freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period.	12 months
Procedure time / Fluoroscopy time / ablation time	12 months
Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.	12 months
Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy	12 months
Quality of life assessments during ≥12-month follow-up (AFEQT)	12 months

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China