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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205461
• Other study ID #: ParisCardioRC
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Paris Cardiovascular Research Center (Inserm U970)
• Contact: Victor Waldmann, MD, MPH
• Phone: +33676098007
• Email: victor.waldmann[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of patient's consent

Related Conditions & MeSH terms

• Congenital Heart Disease
• Fallot Tetralogy
• Heart Diseases
• Pulmonary Valve Insufficiency
• Pulmonary Valve Regurgitation
• Respiratory Insufficiency
• Tetralogy of Fallot
• Ventricular Arrythmia

Intervention

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

Locations

Country	Name	City	State
France	Paris Cardiovascular Research Center	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Paris Cardiovascular Research Center (Inserm U970)	Centre Chirurgical Marie Lannelongue, Clinique Pasteur Toulouse, European Georges Pompidou Hospital, Hopital Louis Pradel, Hôpital Necker-Enfants Malades

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complications associated with programmed ventricular stimulation	Complications considered: death; vascular complications; pericardial effusion; stroke; atrioventricular block; heart failure	1 month
Secondary	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