Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation; Atrial Tachycardia; Atrial Flutter; Congenital Heart Disease; Pulmonary Vein Isolation; Pulsed Field Ablation; Catheter Ablation

• Registration Number: NCT06969378
• Lead Sponsor: Boston Children's Hospital

Brief Summary

This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease (CHD) who are presenting for atrial tachycardia (AT) ablation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-07-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult patients (>= 18 years of age) with repaired or unrepaired congenital heart disease and a history of sustained (>30 seconds) AT

Exclusion Criteria

• History of sustained AF and/or previous catheter or surgical pulmonary vein isolation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major adverse event	1 month	Composite of stroke, transient ischemic attack, cardiac tamponade requiring percutaneous drainage, phrenic nerve injury \>24 hours, atrioesophageal fistula, pulmonary vein stenosis, and/or any bleeding complication requiring blood transfusion.
Acute pulmonary vein isolation	Acute (immediate intraoperative).	Achievement of entrance and exit block to and from all pulmonary veins draining to the left or pulmonary venous atrium.
Time to atrial tachycardia or atrial fibrillation recurrence	12 months	Time to sustained atrial tachycardia (AT) or atrial fibrillation (AF) lasting 30 seconds or more after a 2 month blanking period.

Secondary Outcome Measures

Name	Time	Method
AT/AF Burden	12 months	Daily burden (measured in hours) of AT/AF as measured on an implantable loop recorder after a 2 month blanking period.
Left atrial/pulmonary venous atrial dwell time	Acute (immediate intraoperative)	Time with sheath/catheter in left atrium or pulmonary venous atrium.
Case duration	Acute (immediate intraoperative).	Total procedural duration (minutes)