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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT07068646
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-08-01
• Primary Completion: 2029-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmia recurrence	Within 1 year after 3 months of procedure	Any documented episode of AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period.

Secondary Outcome Measures

Name	Time	Method
Procedure-related cardiac complication rate	30 days after procedure	Open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of