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

Boston Children's Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

Pulsed field ablation using a pentaspline ablation catheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Acute pulmonary vein isolation

Achievement of entrance and exit block to and from all pulmonary veins draining to the left or pulmonary venous atrium.

Time frame: Acute (immediate intraoperative).

Time to atrial tachycardia or atrial fibrillation recurrence

Time to sustained atrial tachycardia (AT) or atrial fibrillation (AF) lasting 30 seconds or more after a 2 month blanking period.

Time frame: 12 months

Major adverse event

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.

Time frame: 1 month

Secondary Outcomes

AT/AF Burden

Daily burden (measured in hours) of AT/AF as measured on an implantable loop recorder after a 2 month blanking period.

Time frame: 12 months

Left atrial/pulmonary venous atrial dwell time

Time with sheath/catheter in left atrium or pulmonary venous atrium.

Time frame: Acute (immediate intraoperative)

Case duration

Total procedural duration (minutes)

Time frame: Acute (immediate intraoperative).

Data from ClinicalTrials.gov

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