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

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Paris Cardiovascular Research Center (Inserm U970)
Updated on 17 March 2021
ventricular septal defect
tetralogy of fallot
septal defect
pulmonary insufficiency
pulmonary valve replacement
right ventricular dilatation


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.

Condition Pulmonary insufficiency, Tetralogy of Fallot, Congenital Heart Defect, Congenital Heart Disease, Heart Defect, VALVULAR HEART DISEASE, Heart Valve Disease, Congenital Heart Disease, Ventricular Arrythmia, Heart Valve Disease, Heart Defect, respiratory insufficiency, pulmonary regurgitation, pulmonic valve insufficiency
Treatment Programmed ventricular stimulation
Clinical Study IdentifierNCT04205461
SponsorParis Cardiovascular Research Center (Inserm U970)
Last Modified on17 March 2021


Yes No Not Sure

Inclusion Criteria

All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement

Exclusion Criteria

Absence of patient's consent
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