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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04205461
Enrollment
100
Registered
2019-12-19
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Absence of patient's consent

Design outcomes

Primary

MeasureTime frameDescription
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillationDuring ventricular programmed stimulationRate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained \> 30 secondes during programmed ventricular stimulation

Secondary

MeasureTime frameDescription
Critical isthmus involved in ventricular tachycardias inducedDuring ventricular programmed stimulationDescription 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 stimulation1 monthComplications considered: * death * vascular complications * pericardial effusion * stroke * atrioventricular block * heart failure
Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement24 monthsSustained ventricular tachycardias or ventricular fibrillations \> 30 secondes and sudden cardiac deaths will be considered

Countries

France

Contacts

Primary ContactVictor Waldmann, MD, MPH
victor.waldmann@gmail.com+33676098007
Backup ContactWided Msakni, MS
wided.msakni@aphp.fr+33156093656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026