NCT07865221Not yet recruiting

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

Clinical Application Evaluation of a Novel Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation and Its Protective Effect on Left Atrial Function

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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).

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 220 (estimated)
First submitted: 28 Sept 2026
Start date: Oct 2026
Primary completion date: Sept 2028
Lead sponsor: Tianjin Medical University General Hospital
Diseases: Atrial fibrillation
NCT number: NCT07865221

What you commit to

Study type: Interventional
Planned participants: 220
From Oct 2026 to the primary completion date, Sept 2028
1 site in 1 country
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.

Prior treatment

Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation.

Other illness

Presence of a cardiac pacemaker or post-left atrial appendage closure.
Severe structural heart disease (e.g., hypertrophic obstructive cardiomyopathy, severe valvular heart disease) or uncontrolled heart failure (NYHA class III or IV).
History of stroke within the past 6 months.
History of surgery within the past 3 months.

Lab values

Thrombocytopenia (PLT \< 80×10\^9/L) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors).
Severe hepatic or renal impairment (AST or ALT \>= 3 times upper limit of normal; SCr \> 3.5 mg/dl or Ccr \< 30 ml/min).

Other

Left atrial anterior-posterior diameter \> 55 mm (by transthoracic echocardiography, parasternal long-axis view).
Left atrial (or left atrial appendage) thrombus (confirmed by TEE or MSCT).
Thyroid dysfunction (e.g., uncontrolled hyperthyroidism).
Pregnant women.
Life expectancy \< 12 months.

Who the study is looking for

Age \>= 18 years.
Symptomatic paroxysmal atrial fibrillation (AF duration \< 7 days).
Ineffective treatment with one or more antiarrhythmic drugs (e.g., propafenone, sotalol, amiodarone).
Discontinued antiarrhythmic drugs for at least 5 half-lives before the procedure.
Willing to receive PFA treatment and postoperative follow-up, and able to sign informed consent.

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

Full criteria on ClinicalTrials.gov

Sites (1)

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

Site	City	Country	Site status
Tianjin Medical University General Hospital Coordinator of this site? Confirm its status	Tianjin	China	Unknown status

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