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

P

Paris Cardiovascular Research Center (Inserm U970)

Status

Unknown

Conditions

Fallot Tetralogy
Ventricular Arrythmia
Congenital Heart Disease
Pulmonary Valve Regurgitation

Treatments

Procedure: Programmed ventricular stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT04205461
ParisCardioRC

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Absence of patient's consent

Trial design

100 participants in 1 patient group

Programmed ventricular stimulation before PVR
Treatment:
Procedure: Programmed ventricular stimulation

Trial contacts and locations

1

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Central trial contact

Victor Waldmann, MD, MPH; Wided Msakni, MS

Data sourced from clinicaltrials.gov

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