Trials / Not Yet Recruiting
Not Yet RecruitingNCT06969378
Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Atrial Fibrillation
- Atrial Tachycardia
- Atrial Flutter
- Congenital Heart Disease
- Pulmonary Vein Isolation
- Pulsed Field Ablation
- Catheter Ablation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2025-05-13
- Last updated
- 2025-05-13
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06969378. Inclusion in this directory is not an endorsement.