Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 498
- Locations
- 12
- Primary Endpoint
- The recurrence rate of atrial tachycardia arrhythmias
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
Detailed Description
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of \>30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).
Investigators
Chang sheng Ma
Director of Cardiology
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The recurrence rate of atrial tachycardia arrhythmias
Time Frame: 1 year
freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
Secondary Outcomes
- Freedom from AF/AT off AADs(1 year)
- Freedom from AF/AT with or without AADs(1 year)
- AFEQT score change between baseline and 12 month(1 year)
- Freedom from AF off AADs(1 year)
- AF burden(1 year)
- Freedom from AF/AT after multiple procedures(1 year)
- EQ5D score change between baseline and 12 month(1 year)
- Incidence of procedural complications(Within 1 month after the procedure)