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

NCT07068646 | Not Yet Recruiting DMC

• 1 other identifier: 4-2025-0458
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmia recurrence

  Any documented episode of AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period.

  Within 1 year after 3 months of procedure

Secondary Outcomes (1)

• Procedure-related cardiac complication rate

  30 days after procedure

Study Arms (2)

CT myocardial thickness map guided PV isolation group

EXPERIMENTAL

Procedure: CT myocardial thickness map guided PV isolation group

Empirical PV isolation group

ACTIVE COMPARATOR

Procedure: Empirical PV isolation group

Interventions

CT myocardial thickness map guided PV isolation group 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.

CT myocardial thickness map guided PV isolation group

Empirical PV isolation group 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.

Empirical PV isolation group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

KR (1)