Clinical trial NCT04205461: Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
Official title: Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Paris Cardiovascular Research Center (Inserm U970)
Sponsor class: OTHER_GOV
Collaborators: name: European Georges Pompidou Hospital
name: Centre Chirurgical Marie Lannelongue
name: Clinique Pasteur Toulouse
name: Hopital Louis Pradel
name: Hôpital Necker-Enfants Malades
First posted: 2019-12-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement

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.


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

Primary outcomes:
measure: Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation
timeFrame: During ventricular programmed stimulation
Secondary outcomes:
measure: Critical isthmus involved in ventricular tachycardias induced
timeFrame: During ventricular programmed stimulation
measure: Complications associated with programmed ventricular stimulation
timeFrame: 1 month
measure: Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Cardiovascular Research Center
Study officials:
affiliation: European Georges Pompidou Hospital
name: Victor Waldmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: