Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

Study Overview
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Brief Summary
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Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch. While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis. At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking. The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.

Official Title
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Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

Conditions
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Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia, Pulmonary Valve Regurgitation

Intervention / Treatment
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* Procedure: Programmed ventricular stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement Exclusion Criteria: Absence of patient's consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Programmed ventricular stimulation before PVR<br> | Procedure: Programmed ventricular stimulation<br>* Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation | Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained > 30 secondes during programmed ventricular stimulation | During ventricular programmed stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical isthmus involved in ventricular tachycardias induced | Description of different critical isthmus involved in ventricular tachycardias induced. Electrophysiological characteristics will be analyzed (conduction velocity, voltage, fragmentation, lenght, width). | During ventricular programmed stimulation | 
| Complications associated with programmed ventricular stimulation | Complications considered: death vascular complications pericardial effusion stroke atrioventricular block heart failure | 1 month | 
| Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement | Sustained ventricular tachycardias or ventricular fibrillations > 30 secondes and sudden cardiac deaths will be considered | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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programmed ventricular stimulation, catheter ablation, electrophysiology study, tetralogy of Fallot, pulmonary valve replacement