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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Pulsed field ablation using a pentaspline ablation catheter

    Device

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Empiric pulsed field pulmonary vein isolationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).
2

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
3

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

1

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
2

Left atrial/pulmonary venous atrial dwell time

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

Time frame
Acute (immediate intraoperative)
3

Case duration

Total procedural duration (minutes)

Time frame
Acute (immediate intraoperative).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Boston Children's Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator

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