How transcatheter pulmonary valves interact with electrical pathways in repaired Tetralogy of Fallot
Official title: Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
Run by Boston Children's Hospital · NCT05236153 · Data updated 2026-11-12
This project will test if detailed right-ventricular electrical mapping before transcatheter pulmonary valve replacement can find conduction isthmuses that might be 'jailed' and linked to ventricular tachycardia in people with repaired Tetralogy of Fallot.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 4, 2022 |
| Main results expected | November 3, 2023 |
| Study ends | January 1, 2024 |
| Registry record updated | February 8, 2023 |
| Trial ID | NCT05236153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with repaired Tetralogy of Fallot or double outlet right ventricle who are referred for transcatheter pulmonary valve replacement and weigh at least 25 kg.
✕Probably not a fit
Patients who are not undergoing TPVR, weigh less than 25 kg, or who already need or have received catheter ablation for ventricular tachycardia are unlikely to gain direct benefit from this mapping-only procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants scheduled for clinically indicated transcatheter pulmonary valve replacement will undergo 3D electroanatomic mapping of the right ventricle using a high-density multielectrode catheter with omnipolar voltage and activation recording. Pre-procedural CT or MRI images will be merged with the electroanatomic map to mark the pulmonary and tricuspid valve annuli and locate anatomic isthmuses relative to the planned valve landing zone. Ventricular pacing at physiologic rates will be used to help distinguish slow conduction from conduction block, and no arrhythmia induction or catheter ablation will be performed. The study will quantify abnormal-voltage or slow-conduction isthmuses and identify which are at risk of being 'jailed' by the valve prosthesis.
Why it matters
Potential benefit: If successful, this approach could help predict which conduction pathways are at risk during TPVR and guide strategies to reduce ventricular tachycardia and sudden death in repaired Tetralogy of Fallot.
How similar studies have gone: High-density electroanatomic mapping and omnipolar techniques have been useful for identifying ventricular scar and slow conduction in other populations, but using them specifically to predict TPVR-related 'jailing' of isthmuses in repaired Tetralogy of Fallot is largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of tetralogy of Fallot (TOF) or double outlet right ventricle (DORV) * Referred for transcatheter pulmonary valve replacement (TPVR) per routine clinical indications * Weight \>=25 kg
Where it's running
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Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Edward T O'Leary, MD — Boston Children's Hospital
- Study coordinator: Edward T O'Leary, MD
- Email: edward.oleary@cardio.chboston.org
- Phone: 617-355-7833
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.