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

• Conditions: Congenital Heart Disease; Fallot Tetralogy; Ventricular Arrythmia; Pulmonary Valve Regurgitation
• Interventions: Procedure: Programmed ventricular stimulation

• Registration Number: NCT04205461
• Lead Sponsor: Paris Cardiovascular Research Center (Inserm U970)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Absence of patient's consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Programmed ventricular stimulation before PVR	Programmed ventricular stimulation	-

Primary Outcome Measures

Name	Time	Method
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation	During ventricular programmed stimulation	Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained \> 30 secondes during programmed ventricular stimulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Paris Cardiovascular Research Center; 🇫🇷 Paris, France