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

NCT06969378 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IRB-P00049906
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Atrial Tachycardia; Atrial Flutter; Congenital Heart Disease; Pulmonary Vein Isolation; Pulsed Field Ablation; Catheter Ablation

Keywords

atrial fibrillation; atrial tachycardia; atrial flutter; pulsed field ablation; congenital heart disease; adult congenital heart disease; pulmonary vein isolation; catheter ablation

Outcome Measures

Primary Outcomes (3)

• Acute pulmonary vein isolation

  Achievement of entrance and exit block to and from all pulmonary veins draining to the left or pulmonary venous atrium.

  Acute (immediate intraoperative).

• 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.

  12 months

• 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.

  1 month

Secondary Outcomes (3)

• AT/AF Burden

  12 months

• Left atrial/pulmonary venous atrial dwell time

  Acute (immediate intraoperative)

• Case duration

  Acute (immediate intraoperative).

Study Arms (1)

Empiric pulsed field pulmonary vein isolation

EXPERIMENTAL

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.

Device: Pulsed field ablation using a pentaspline ablation catheter

Interventions

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.

Empiric pulsed field pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Brigham and Women's Hospital: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Edward O'Leary, MD

CONTACT

6173557833; toleary87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share