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

NCT04205461 | Unknown DMC

• 1 other identifier: ParisCardioRC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Fallot Tetralogy; Ventricular Arrythmia; Pulmonary Valve Regurgitation

Keywords

programmed ventricular stimulation; catheter ablation; electrophysiology study; tetralogy of Fallot; pulmonary valve replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (1)

Programmed ventricular stimulation before PVR

Procedure: Programmed ventricular stimulation

Interventions

Programmed ventricular stimulation PROCEDURE

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

Programmed ventricular stimulation before PVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Absence of patient's consent

Sponsors & Collaborators

• Paris Cardiovascular Research Center (Inserm U970): lead
• European Georges Pompidou Hospital: collaborator
• Centre Chirurgical Marie Lannelongue: collaborator
• Clinique Pasteur Toulouse: collaborator
• Hopital Louis Pradel: collaborator
• Hôpital Necker-Enfants Malades: collaborator

Study Sites (1)

Paris Cardiovascular Research Center

Paris, 75015, France

RECRUITING

Related Publications (1)

• Waldmann V, Bessiere F, Gardey K, Bakloul M, Belli E, Bonnet D, Chaussade AS, Cohen S, Delasnerie H, Dib N, Di Filippo S, Dulac A, Hascoet S, Henaine R, Iserin L, Karsenty C, Ladouceur M, Legendre A, Malekzadeh-Milani S, Mostefa Kara M, Radojevic J, Ratsimandresy M, Marijon E, Maltret A, Khairy P, Combes N. Systematic Electrophysiological Study Prior to Pulmonary Valve Replacement in Tetralogy of Fallot: A Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011745. doi: 10.1161/CIRCEP.122.011745. Epub 2023 May 12.

  PMID: 37170812 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases

Study Officials

• Victor Waldmann, MD, MPH

  European Georges Pompidou Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Waldmann, MD, MPH

CONTACT

+33676098007; victor.waldmann@gmail.com

Wided Msakni, MS

CONTACT

+33156093656; wided.msakni@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 19, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

FR (1)