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Clinical Trials in China / NCT06729866
Active, not recruiting Not applicable

EGM Guided PFA for PerAF

NCT06729866 · tracked via the Priya Life Science China tracker
Sponsor
Xu Liu
Phase
Not applicable
Started
2024-09-20
Last updated
2025-06-04

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

electrogram guided pulse field ablation

electrogram guided pulse field ablation: In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.

Study summary

Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria: 1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent 2. ECG-documented episode of persistent AF lasting longer than 7 days 3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF 2. Patients who are ≥ 18 years 3. Patient participation requirements: 1. Is willing and capable of providing Informed Consent to undergo study procedures 2. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study. Exclusion Criteria: 1. AF that is: 1. Paroxysmal (longest AF episode \< 7days) 2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes 2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) 3. Any of the following cardiac conditions: 1. Clinically significant arrhythmias other than AF, AFL or AT 2. NYHA Class IV CHF 3. Atrial or ventricular septal defect closure 4. Atrial myxoma 5. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following within 3 months of enrollment: 1. Myocardial infarction 2. Unstable angina 3. Percutaneous coronary intervention 4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy) 5. Heart failure hospitalization 6. Stroke or TIA 7. Clinically significant bleeding 8. Pericarditis or pericardial effusion 9. 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 premedication 8. Women of childbearing potential who are pregnant, lactating or not using birth control 9. 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 to 1. Body mass index (BMI) \> 40 transplant 2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea 3. Renal insufficiency with an estimated creatinine clearance \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant 4. Active malignancy or history of treated cancer within 24 months of enrollment 5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux 6. Clinically significant infection 7. Predicted life expectancy less than one year 10. Current or anticipated enrollment in any other clinical study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06729866 on ClinicalTrials.gov ↗ ← All trials in China