Pulsed-Field Ablation for Atrial Fibrillation

(PEAK-AF Trial)

Not currently recruiting at 9 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Xu Liu
Must be taking: Class I/III antiarrhythmics
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am 18-79, have persistent AF not controlled by medication, and can join all study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, 12, and 36 months

36 months
Multiple visits (in-person and virtual)

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

Group I: EGMExperimental Treatment1 Intervention
Group II: PWIActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xu Liu

Lead Sponsor

Trials
4
Recruited
720+

Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine

Collaborator