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

Boston Children's Hospital

Status: Not yet enrolling

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

Treatments: Device: Pulsed field ablation using a pentaspline ablation catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06969378

IRB-P00049906

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Empiric pulsed field pulmonary vein isolation

Experimental group

Description:

Patients will receive general endotracheal anesthesia or conscious sedation provided by cardiac anesthesiology and usual vascular access for their clinically indicated catheter ablation for AT. Usual diagnostic methods including programmed electrical stimulation for arrhythmia induction and electroanatomic activation and voltage mapping will be performed followed by RFA (using standard-of-care, commercially-available RFA catheters) of any observed AT. 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.

Treatment:

Device: Pulsed field ablation using a pentaspline ablation catheter