Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation

Shanghai Chest Hospital384 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

384

Conditions

Persistent Atrial Fibrillation

Interventions

PVIPROCEDURE

PVI

PWIPROCEDURE

PWI

EGMPROCEDURE

EGM

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months

Time frame: 12 months

Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: 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.

Time frame: 12 months

Central Contacts

Mu Qin

CONTACT

13052320103 qinmuae@163.com

Xumin Hou

CONTACT

houxumin@shchest.org

Data from ClinicalTrials.gov

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