Recruiting NCT07122336
Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PVI, PWI, EGM.
- Who it may be relevant to
- Registry conditions: Persistent Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Procedure PVI
PVI - Procedure PWI
PWI - Procedure EGM
EGM
Primary outcome measures
- 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 outcome measures (9)
- 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]
- Procedure time / Fluoroscopy time / ablation time [Time frame: 12 months]
- Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality. [Time frame: 12 months]
- Quality of life assessments during ≥12-month follow-up (AFEQT) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- First-time ablation for persistent atrial fibrillation (PsAF)
- Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
- Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
- 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
- Ability and willingness to provide written informed consent
- Compliance with all study follow-up requirements
Exclusion criteria
- Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
- Long-standing persistent AF: Continuous AF duration >3 years
- No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
- Contraindications to systemic anticoagulation
- Pregnancy
- Advanced renal or hepatic failure
- Severe valvular heart disease or cyanotic congenital heart disease
- Hypertrophic cardiomyopathy (HCM)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07122336 · OAPWAF