Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot

What this Trial Is About

Researchers are studying individuals with repaired Tetralogy of Fallot rTOF who remain at risk for sudden cardiac death due to ventricular tachycardia VT. This study aims to understand how transcatheter pulmonary valve replacement TPVR affects the hearts electrical pathways, specifically the right ventricular RV isthmuses, and to explore new technology for mapping heart electrical activity. The goal is to better identify and characterize areas at risk during TPVR procedures. Participants will undergo TPVR as part of their standard care. Before the valve is placed, a detailed 3-dimensional electroanatomic map of the RV will be created using a specialized high-density catheter and mapping system. This mapping includes overlaying prior imaging and assessing heart electrical activity during normal rhythm and paced heartbeats. No attempts will be made to induce arrhythmias or perform ablation during the procedure. After the procedure, participants will be followed for 10 years to track heart rhythm events such as ventricular tachycardia, ventricular fibrillation, ICD placement or shocks, and sudden cardiac arrest or death. Annual medical record reviews will support this long-term monitoring. The study measures the area of RV isthmuses affected by the valve immediately after TPVR and monitors arrhythmic events over time.

Electroanatomic Interactions Between Transcatheter Pulmonary Valve Prostheses and Anatomic Isthmuses in Repaired Tetralogy of Fallot