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

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.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Freedom from atrial arrhythmia recurrence

Time frame: 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 outcomes

Procedure-related cardiac complication rate

Time frame: 30 days after procedure

Open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Computed Tomogram Myocardial Thickness Map-Guided Pulmonary Vein Isolation vs. Empirical Pulmonary Vein Isolation in Pulse-Field Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF III)

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jul 16, 2025
Registry last updated: Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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