Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia, Catheter Ablation, Congenital Heart Disease, Pulmonary Vein Isolation, Pulsed Field Ablation
Conditions
Keywords
atrial fibrillation, atrial tachycardia, atrial flutter, pulsed field ablation, congenital heart disease, adult congenital heart disease, pulmonary vein isolation, catheter ablation
Brief summary
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.
Interventions
DEVICEPulsed 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.
Sponsors
Boston Children's Hospital
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute pulmonary vein isolation | Acute (immediate intraoperative). | 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 | 12 months | Time to sustained atrial tachycardia (AT) or atrial fibrillation (AF) lasting 30 seconds or more after a 2 month blanking period. |
| Major adverse event | 1 month | 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
| Measure | Time frame | Description |
|---|---|---|
| AT/AF Burden | 12 months | 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 | Acute (immediate intraoperative) | Time with sheath/catheter in left atrium or pulmonary venous atrium. |
| Case duration | Acute (immediate intraoperative). | Total procedural duration (minutes) |
Outcome results
None listed