Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease
NCT ID: NCT06969378
Last Updated: 2025-05-13
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Empiric pulsed field pulmonary vein isolation
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Edward O'Leary
Physician
Central Contacts
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Other Identifiers
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IRB-P00049906
Identifier Type: -
Identifier Source: org_study_id
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