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

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 Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Ventricular Arrythmia; Pulmonary Valve Regurgitation; Fallot Tetralogy
• Intervention / Treatment: Procedure: Programmed ventricular stimulation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Wided Msakni, MS; Phone Number: +33156093656; Email: wided.msakni@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Paris Cardiovascular Research Center
    • Contact: Wided Msakni, MS; Phone Number: +33156093656; Email: wided.msakni@aphp.fr
    • Principal Investigator: Victor Waldmann, MD, MPH
    • Principal Investigator: Nicolas Combes, MD
    • Sub-Investigator: Francis Bessiere, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Programmed ventricular stimulation before PVR	Procedure: Programmed ventricular stimulation; Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation	Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained > 30 secondes during programmed ventricular stimulation	During ventricular programmed stimulation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Paris Cardiovascular Research Center (Inserm U970)
• Collaborators: European Georges Pompidou Hospital; Centre Chirurgical Marie Lannelongue; Hôpital Necker-Enfants Malades; Hopital Louis Pradel; Clinique Pasteur Toulouse
• Investigators: Principal Investigator: Victor Waldmann, MD, MPH, European Georges Pompidou Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: catheter ablation; pulmonary valve replacement; tetralogy of Fallot; electrophysiology study; programmed ventricular stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Cardiovascular Abnormalities; Heart Diseases; Tetralogy of Fallot; Heart Defects, Congenital; Pulmonary Valve Insufficiency
• Other Study ID Numbers: ParisCardioRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No