Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF

Yonsei University

Status

Not yet enrolling

Conditions

Atrial Fibrillation

Treatments

Procedure: CT myocardial thickness map guided PV isolation group

Procedure: Empirical PV isolation group

Study type

Interventional

Funder types

Other

Identifiers

NCT07068646

4-2025-0458

Details and patient eligibility

About

This is a prospective, multicenter, randomized controlled trial comparing CT-guided versus empirical pulsed field ablation (PFA) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. The study investigates whether atrial wall thickness-based energy titration improves arrhythmia outcomes compared to standard empirical ablation using the PulseSelect™ system.

Full description

Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) is an effective and increasingly adopted strategy for the treatment of paroxysmal atrial fibrillation (AF). However, current empirical lesion protocols do not account for patient-specific anatomical variability, particularly atrial wall thickness, which may influence lesion durability. This randomized controlled trial aims to evaluate whether a CT-guided ablation strategy-using pre-procedural atrial wall thickness maps to titrate lesion application-can improve rhythm outcomes compared to standard empirical PFA. A total of 298 patients will be enrolled and randomized to either the CT-guided or empirical group, with follow-up over 12 months to assess freedom from atrial arrhythmia recurrence and procedure-related safety outcomes.

Enrollment

298 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥19 and ≤80 years of age
Left atrium size < 50mm
paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

Exclusion Criteria:

Patients with persistent or permanent atrial fibrillation
Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
Patients with severe renal impairment or CT imaging difficulty using contrast media
Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
Patients with active internal bleeding
Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
Patients with valvular atrial fibrillation (mitral stenosis >grade 2, mechanical valve, mitral valvuloplasty)
Patients with a severe comorbid disease
Expected survival < 1 year
Drug addicts or alcoholics
Patients who cannot read the consent form (illiterates, foreigners, etc.)
Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study