Pulsed-Field Ablation With/Without Electrogram Mapping

Running, not enrolling · Not applicable

Conditions studied: Non-paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID: NCT07541989
Run by: Xu Liu
People needed: 300
Starts: 2024-09-30
Expected to finish: 2028-06-01
Last updated by the study team: 2026-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agentb. ECG-documented episode of persistent AF lasting longer than 7 days c. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF2. Patients who are ≥ 18 years and <80 years 3. Patient participation requirements:a. Is willing and capable of providing Informed Consent to undergo study proceduresb. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if…

1. AF that is:a. Paroxysmal (longest AF episode < 7days)b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)3. Any of the following cardiac conditions:a. Clinically significant arrhythmias other than AF, AFL or ATb. NYHA Class IV CHFc. Atrial or ventricular septal defect closured. Atrial myxomae. History of congenital heart disease with any residual anatomic or conduction abnormality4. Any of the following within 3 months of enrollment:a. Myocardial infarctionb. Unstable anginac. Percutaneous coronary interventiond. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)e. Heart failure hospitalizationf. Stroke or TIAg. Clinically significant bleedingh. Pericarditis or pericardial effusioni. Left atrial thrombus 5. History of blood clotting or bleeding abnormalities.6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Sensitivity to contrast media not controlled by premedication8. Women of childbearing potential who are pregnant, lactating or not using birth control9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited toa. Body mass index (BMI) > 40 transplantb. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspneac. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant d. Active malignancy or history of treated cancer within 24 months of enrollmente. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid refluxf. Clinically significant infectiong. Predicted life expectancy less than one year10. Current or anticipated enrollment in any other clinical study

Where it is running

Montefiore Medical Center — The Bronx, New York, United States
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
Changshu Hospital of Traditional Chinese Medicine — Changshu, Jiangsu, China
Xuzhou Central Hospital — Xuzhou, Jiangsu, China
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China
Jinan City People's Hospital — Jinan, Shandong, China
Wenling Hospital of Traditional Chinese Medicine — Wenling, Zhejiang, China
Yuhuan Second People's Hospital — Yuhuan, Zhejiang, China
Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital — Shanghai, China
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai — Shanghai, China

Full record on ClinicalTrials.gov

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