Pulsed-Field Ablation for Atrial Fibrillation
(PEAK-AF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. In addition to anatomical lesion sets such as PVI and posterior wall isolation (PWI), Electrogram Mapping of Key Substrates may allow identification of residual arrhythmogenic areas that contribute to the maintenance of atrial fibrillation. In the investigators' previously completed single-center cohort study, adjunctive ablation targeting key substrates identified by electrogram mapping on top of PVI+PWI was feasible and associated with improved rhythm outcomes.
This prospective multicenter randomized controlled study is designed to compare PFA-based PVI+PWI alone versus PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates in patients with non-paroxysmal atrial fibrillation, in order to evaluate the efficacy and safety of this strategy in a broader and more rigorous clinical setting.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), with or without adjunctive ablation guided by Electrogram Mapping of Key Substrates
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 36 months
What Are the Treatments Tested in This Trial?
Interventions
- Electrogram Mapping
- Pulsed-Field Ablation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates: Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), followed by adjunctive ablation targeting key atrial substrates identified by predefined electrogram mapping criteria.
Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) without adjunctive ablation guided by electrogram mapping of key substrates.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xu Liu
Lead Sponsor
Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine
Collaborator
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