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

NCT ID: NCT07068646

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-07-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT myocardial thickness map guided PV isolation group

Group Type: EXPERIMENTAL

CT myocardial thickness map guided PV isolation group

Intervention Type: PROCEDURE

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system. A pre-procedural cardiac CT scan will be used to generate an atrial myocardial thickness map. In this group, atrial segments with wall thickness \>2.5 mm identified on the CT map will receive additional PFA applications (up to 8 per PV) to ensure transmural lesion formation. All other segments will receive the standard minimum of 8 applications per vein. The ablation catheter will remain stationary to allow lesion stacking when needed.

Empirical PV isolation group

Group Type: ACTIVE_COMPARATOR

Empirical PV isolation group

Intervention Type: PROCEDURE

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system according to a standardized empirical protocol. Each pulmonary vein will receive a minimum of 8 PFA applications without adjustment based on anatomical or CT-based parameters. Additional applications may be delivered at the operator's discretion based on procedural findings, but no wall thickness mapping will be used.

Interventions

CT myocardial thickness map guided PV isolation group

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system. A pre-procedural cardiac CT scan will be used to generate an atrial myocardial thickness map. In this group, atrial segments with wall thickness \>2.5 mm identified on the CT map will receive additional PFA applications (up to 8 per PV) to ensure transmural lesion formation. All other segments will receive the standard minimum of 8 applications per vein. The ablation catheter will remain stationary to allow lesion stacking when needed.

Intervention Type: PROCEDURE

Empirical PV isolation group

Pulmonary vein isolation will be performed using the PulseSelect™ pulsed field ablation system according to a standardized empirical protocol. Each pulmonary vein will receive a minimum of 8 PFA applications without adjustment based on anatomical or CT-based parameters. Additional applications may be delivered at the operator's discretion based on procedural findings, but no wall thickness mapping will be used.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2025-0458

Identifier Type: -

Identifier Source: org_study_id