Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
NCT ID: NCT04205461
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-01-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Programmed ventricular stimulation before PVR
Programmed ventricular stimulation
Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.
Interventions
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Programmed ventricular stimulation
Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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European Georges Pompidou Hospital
OTHER
Centre Chirurgical Marie Lannelongue
OTHER
Clinique Pasteur Toulouse
OTHER
Hopital Louis Pradel
OTHER
Hôpital Necker-Enfants Malades
OTHER
Paris Cardiovascular Research Center (Inserm U970)
OTHER_GOV
Responsible Party
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Principal Investigators
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Victor Waldmann, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
European Georges Pompidou Hospital
Locations
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Paris Cardiovascular Research Center
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ParisCardioRC
Identifier Type: -
Identifier Source: org_study_id
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