Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: Clinical Efficacy and Left Atrial Function Protection

NCT07865221 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Medical University General Hospital

Phase

Not applicable

Started

2026-10

Last updated

2026-10-14

Condition(s) studied

Paroxysmal Atrial FibrillationPulsed Field AblationCatheter AblationLeft Atrial FunctionCardiology

Investigational drug(s) / intervention(s)

Novel Pulsed Field Ablation SystemRadiofrequency Ablation Catheter

Novel Pulsed Field Ablation System: Use a novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system to perform pulmonary vein isolation.

Radiofrequency Ablation Catheter: Use conventional radiofrequency ablation catheters to perform pulmonary vein isolation.

Study summary

This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess its protective effect on left atrial function.

Approximately 200-220 patients with paroxysmal atrial fibrillation are planned to be enrolled. Participants will be treated with the novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system.

The primary objectives include:

Efficacy: Immediate pulmonary vein isolation success rate, and freedom from atrial arrhythmias (\>30 seconds) at 12 months post-procedure.

Safety: Incidence of major complications (such as cardiac tamponade, stroke, pulmonary vein stenosis, phrenic nerve palsy).

Left Atrial Function: Dynamic changes in echocardiographic parameters (e.g., LAVI, LVEF, E/A, LASr/cd/ct) and serum biomarkers (e.g., troponin, BNP, inflammatory markers) at multiple time points before and after the procedure.

Patients will be followed up for 12 months to evaluate the long-term outcomes and quality of life improvement (EQ-5D-5L). The study duration is expected to be 36 months (October 2025 to September 2028).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age \>= 18 years. 2. Symptomatic paroxysmal atrial fibrillation (AF duration \< 7 days). 3. Ineffective treatment with one or more antiarrhythmic drugs (e.g., propafenone, sotalol, amiodarone). 4. Discontinued antiarrhythmic drugs for at least 5 half-lives before the procedure. 5. Willing to receive PFA treatment and postoperative follow-up, and able to sign informed consent. Exclusion Criteria: 1. Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation. 2. Presence of a cardiac pacemaker or post-left atrial appendage closure. 3. Thrombocytopenia (PLT \< 80×10\^9/L) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors). 4. Left atrial anterior-posterior diameter \> 55 mm (by transthoracic echocardiography, parasternal long-axis view). 5. Left atrial (or left atrial appendage) thrombus (confirmed by TEE or MSCT). 6. Severe structural heart disease (e.g., hypertrophic obstructive cardiomyopathy, severe valvular heart disease) or uncontrolled heart failure (NYHA class III or IV). 7. Thyroid dysfunction (e.g., uncontrolled hyperthyroidism). 8. Severe hepatic or renal impairment (AST or ALT \>= 3 times upper limit of normal; SCr \> 3.5 mg/dl or Ccr \< 30 ml/min). 9. History of stroke within the past 6 months. 10. History of surgery within the past 3 months. 11. Pregnant women. 12. Life expectancy \< 12 months.

Primary outcome measure(s)

Freedom from atrial arrhythmia recurrence at 12 months — 12 months post-procedure
Percentage of participants free from documented atrial arrhythmias (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting \>30 seconds at 12 months post-ablation.
Incidence of major procedure-related complications — Within 12 months post-procedure
Incidence of major adverse events related to the procedure, such as cardiac tamponade, thromboembolic events, vascular complications, pulmonary vein stenosis, and phrenic nerve injury.

Trial sites (1)

Facility	City	Region	Status
Tianjin Medical University General Hospital	Tianjin	Tianjin Municipality

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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 NCT07865221 on ClinicalTrials.gov ↗ ← All trials in China