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Clinical Trials/NCT04205461
NCT04205461
Unknown
Not Applicable

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

Paris Cardiovascular Research Center (Inserm U970)1 site in 1 country100 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Paris Cardiovascular Research Center (Inserm U970)
Enrollment
100
Locations
1
Primary Endpoint
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Paris Cardiovascular Research Center (Inserm U970)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Absence of patient's consent

Outcomes

Primary Outcomes

Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation

Time Frame: During ventricular programmed stimulation

Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained \> 30 secondes during programmed ventricular stimulation

Secondary Outcomes

  • Critical isthmus involved in ventricular tachycardias induced(During ventricular programmed stimulation)
  • Complications associated with programmed ventricular stimulation(1 month)
  • Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement(24 months)

Study Sites (1)

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