How transcatheter pulmonary valves interact with electrical pathways in repaired Tetralogy of Fallot
Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot
NA · Boston Children's Hospital · NCT05236153
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05236153 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tetralogy of Fallot, Ventricular Tachycardia, Sudden Cardiac Death