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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Procedure: Programmed ventricular stimulation
    • Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.

Arms, Groups and Cohorts

  • Programmed ventricular stimulation before PVR

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Critical isthmus involved in ventricular tachycardias induced
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 24 months
    • Sustained ventricular tachycardias or ventricular fibrillations > 30 secondes and sudden cardiac deaths will be considered

Participating in This Clinical Trial

Inclusion Criteria

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

  • Absence of patient's consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paris Cardiovascular Research Center (Inserm U970)
  • Collaborator
    • European Georges Pompidou Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Victor Waldmann, MD, MPH, Principal Investigator, European Georges Pompidou Hospital
  • Overall Contact(s)
    • Victor Waldmann, MD, MPH, +33676098007, victor.waldmann@gmail.com

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