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

NCT07068646 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2025-07-16

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068646 on ClinicalTrials.gov