Persistent Atrial Fibrillation
Conditions
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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 |
| Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months | 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 |
| Quality of life assessments during ≥12-month follow-up (AFEQT) | 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 |
Countries
China
Contacts
Primary ContactMu Qin
Backup ContactXumin Hou
Outcome results
None listed