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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Pulsed field ablation using a pentaspline ablation catheter
DeviceAfter 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
Trial 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 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.
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.
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.
Left atrial/pulmonary venous atrial dwell time
Time with sheath/catheter in left atrium or pulmonary venous atrium.
Case duration
Total procedural duration (minutes)
Locations
Sponsors and contacts
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Boston Children's Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
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