Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: EGM; Procedure: PWI; Procedure: PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT07122336

OAPWAF

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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384 participants in 3 patient groups

PVI group

Sham Comparator group

Description:

PVI

Treatment:

Procedure: PVI

PVI+ PWI group

Experimental group

Description:

PVI+ PWI

Treatment:

Procedure: PVI

Procedure: PWI

PVI+ PWI+EGM group

Experimental group

Description:

PVI+ PWI+EGM

Treatment:

Procedure: PVI

Procedure: PWI

Procedure: EGM