Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-21 @ 3:42 PM
Study NCT ID:
NCT04205461
Status:
UNKNOWN
Last Update Posted:
2021-03-09
First Post:
2019-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D013771', 'term': 'Tetralogy of Fallot'}, {'id': 'D011665', 'term': 'Pulmonary Valve Insufficiency'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation', 'timeFrame': 'During ventricular programmed stimulation', 'description': 'Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained \\> 30 secondes during programmed ventricular stimulation'}], 'secondaryOutcomes': [{'measure': 'Critical isthmus involved in ventricular tachycardias induced', 'timeFrame': 'During ventricular programmed stimulation', 'description': 'Description of different critical isthmus involved in ventricular tachycardias induced. Electrophysiological characteristics will be analyzed (conduction velocity, voltage, fragmentation, lenght, width).'}, {'measure': 'Complications associated with programmed ventricular stimulation', 'timeFrame': '1 month', 'description': 'Complications considered:\n\n* death\n* vascular complications\n* pericardial effusion\n* stroke\n* atrioventricular block\n* heart failure'}, {'measure': 'Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement', 'timeFrame': '24 months', 'description': 'Sustained ventricular tachycardias or ventricular fibrillations \\> 30 secondes and sudden cardiac deaths will be considered'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['programmed ventricular stimulation', 'catheter ablation', 'electrophysiology study', 'tetralogy of Fallot', 'pulmonary valve replacement'], 'conditions': ['Congenital Heart Disease', 'Fallot Tetralogy', 'Ventricular Arrythmia', 'Pulmonary Valve Regurgitation']}, 'referencesModule': {'references': [{'pmid': '37170812', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nVentricular 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.\n\nWhile 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.\n\nAt present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement\n\nExclusion Criteria:\n\n* Absence of patient's consent"}, 'identificationModule': {'nctId': 'NCT04205461', 'briefTitle': 'Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Paris Cardiovascular Research Center (Inserm U970)'}, 'officialTitle': 'Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot', 'orgStudyIdInfo': {'id': 'ParisCardioRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Programmed ventricular stimulation before PVR', 'interventionNames': ['Procedure: Programmed ventricular stimulation']}], 'interventions': [{'name': 'Programmed ventricular stimulation', 'type': 'PROCEDURE', 'description': 'Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.', 'armGroupLabels': ['Programmed ventricular stimulation before PVR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victor Waldmann, MD, MPH', 'role': 'CONTACT', 'email': 'victor.waldmann@gmail.com', 'phone': '+33676098007'}, {'name': 'Wided Msakni, MS', 'role': 'CONTACT', 'email': 'wided.msakni@aphp.fr', 'phone': '+33156093656'}, {'name': 'Victor Waldmann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas Combes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francis Bessiere, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Paris Cardiovascular Research Center', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Victor Waldmann, MD, MPH', 'role': 'CONTACT', 'email': 'victor.waldmann@gmail.com', 'phone': '+33676098007'}, {'name': 'Wided Msakni, MS', 'role': 'CONTACT', 'email': 'wided.msakni@aphp.fr', 'phone': '+33156093656'}], 'overallOfficials': [{'name': 'Victor Waldmann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Georges Pompidou Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris Cardiovascular Research Center (Inserm U970)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, {'name': 'Clinique Pasteur Toulouse', 'class': 'OTHER'}, {'name': 'Hopital Louis Pradel', 'class': 'OTHER'}, {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}