Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01250327
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2010-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-16', 'studyFirstSubmitDate': '2010-11-27', 'studyFirstSubmitQcDate': '2010-11-29', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost induced by the transcatheter pulmonary valve insertion as compared to conventional surgical and insertion of a bare metal stent 24 months after insertion.', 'timeFrame': '24 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '24 months after intervention'}, {'measure': 'procedure success rate', 'timeFrame': '24 months after intervention'}, {'measure': 'Does the patient need to be operated again?', 'timeFrame': '24 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['right ventricular outflow tract', 'endovascular valve insertion', 'economic evaluation', 'valved stent'], 'conditions': ['Dysfunction of the Prosthetic Conduct', 'Lesions of the Right Ventricular Outflow Tract']}, 'referencesModule': {'references': [{'pmid': '25453718', 'type': 'DERIVED', 'citation': 'Fraisse A, Aldebert P, Malekzadeh-Milani S, Thambo JB, Piechaud JF, Aucoururier P, Chatelier G, Bonnet D, Iserin L, Bonello B, Assaidi A, Kammache I, Boudjemline Y. Melody (R) transcatheter pulmonary valve implantation: results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).', 'detailedDescription': 'Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.\n\nMain objective : evaluate the cost of the procedure as compared with conventional technique.\n\nDesign : multicenter intervention prospective study. Population : 180 patients in three arms (3\\*60).\n\nEnd point criteria :\n\n* Primary : cost\n* Secondary : rate of reoperation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfor the study:\n\n* Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation\n\nfor the Melody arm:\n\n* A 5 to 70 years old patient\n* Weight \\>= 30kg\n* RVOT \\<= to 22mm\n* Patient with a dysfunction circumferential prosthetic conduct of diameter \\>= to 16mm.\n\nExclusion Criteria:\n\n* Vein anatomy incompatibility with a 22Fr delivery health\n* Left heart implantation\n* RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)\n* Coronary anomaly with a coronary artery naer the RVOT\n* Sever obstruction of the RVOT incompatible with balloon expansion\n* Central vein obstruction\n* Ongoing infection\n* Active endocarditis\n* Allergy for heparin or aspirin\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01250327', 'acronym': 'REVALV', 'briefTitle': 'Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement for the Treatment of Lesions of the Ventricular Outflow Tract.', 'orgStudyIdInfo': {'id': 'P080205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melody', 'description': 'insertion of a pulmonic valved stent', 'interventionNames': ['Device: Melody']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bare stent', 'description': 'insertion of a bare metal stent', 'interventionNames': ['Device: bare stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'conventional surgery methode.', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Melody', 'type': 'DEVICE', 'otherNames': ['insertion of a pulmonic valved stent'], 'description': 'insertion of a pulmonic valved stent', 'armGroupLabels': ['Melody']}, {'name': 'bare stent', 'type': 'DEVICE', 'otherNames': ['insertion of a bare metal stent'], 'description': 'insertion of a bare metal stent', 'armGroupLabels': ['Bare stent']}, {'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['conventional surgery methode'], 'description': 'conventional surgery methode', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Boudjemline Younes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}