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NCT07541989Active, not recruiting

Pulsed-Field Ablation With/Without Electrogram Mapping

Pulsed-Field Ablation With/Without Electrogram Mapping of Key Substrates for Non-paroxysmal Atrial Fibrillation: A Prospective Multicenter Randomized Study (PEAK-AF Study)

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
13 Apr 2026
Start date
30 Sept 2024
Primary completion date
1 May 2028
Lead sponsor
Xu Liu
NCT number
NCT07541989

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 30 Sept 2024 to the primary completion date, 1 May 2028
  • 10 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changshu Hospital of Traditional Chinese Medicine
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ChangshuChinaUnknown status
Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
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JinanChinaUnknown status
Jinan City People's Hospital
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JinanChinaUnknown status
Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai
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ShanghaiChinaUnknown status
Wenling Hospital of Traditional Chinese Medicine
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WenlingChinaUnknown status
The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Xuzhou Central Hospital
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XuzhouChinaUnknown status
Yuhuan Second People's Hospital
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YuhuanChinaUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.