Pulsed-Field Ablation With/Without Electrogram Mapping (NCT07541989)
Pulsed-Field Ablation With/Without Electrogram Mapping of Key Substrates for Non-paroxysmal Atrial Fibrillation: A Prospective Multicenter Randomized Study (PEAK-AF Study)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Montefiore Medical Center — The Bronx, New York
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
- PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates (PROCEDURE)
- PFA-based PVI+PWI alone (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Montefiore Medical Center — The Bronx, New York
- The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei
- Changshu Hospital of Traditional Chinese Medicine — Changshu, Jiangsu
- Xuzhou Central Hospital — Xuzhou, Jiangsu
- Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong
- Jinan City People's Hospital — Jinan, Shandong
- Wenling Hospital of Traditional Chinese Medicine — Wenling, Zhejiang
- Yuhuan Second People's Hospital — Yuhuan, Zhejiang
- Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital — Shanghai,
- Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai — Shanghai,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Non-paroxysmal Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.