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NOT YET RECRUITING
NCT06969378
NA

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

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-07-01

Completion Date

2026-06-30

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

DEVICE

Pulsed field ablation using a pentaspline ablation catheter

After conclusion of AT ablation, transseptal or transbaffle puncture will be performed under fluoroscopic and intracardiac echocardiography guidance to access the left atrium (LA) or pulmonary venous atrium (PVA) if not already done so. PFA will be performed using a pentaspline catheter (Farawave, Boston Scientific) and a steerable sheath to achieve PVI of all veins draining to the LA/PVA with entrance and exit block confirmed at each vein. In patients where PFA is unable to achieve PVI, touch-up RFA will be performed. Programmed atrial stimulation will be performed to investigate for inducible atrial tachycardias. An implantable loop recorder will be placed at the conclusion of the procedure.