Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation (AF)
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Freedom from Atrial Arrhythmia Recurrence at 12 Months
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
Investigators
Xu Liu
MD
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
- •Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
Exclusion Criteria
- •Major valvular diseases needing surgical intervention.
- •Presence of a left atrial thrombus on recent imaging.
- •Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
- •Current Severe Infection.
Outcomes
Primary Outcomes
Freedom from Atrial Arrhythmia Recurrence at 12 Months
Time Frame: 12 months after ablation procedure
Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.
Secondary Outcomes
- Procedural Safety(From enrollment to completion of follow-up（at least 12 months）)
- Symptom Relief and Quality of Life Enhancement.(From enrollment to completion of follow-up（at least 12 months）)
- Atrial Fibrillation Burden Reduction(From enrollment to completion of follow-up（at least 12 months）)