Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-05 @ 5:52 PM
Study NCT ID:
NCT03495050
Status:
UNKNOWN
Last Update Posted:
2018-06-12
First Post:
2018-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082882', 'term': 'Bicuspid Aortic Valve Disease'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-10', 'studyFirstSubmitDate': '2018-03-03', 'studyFirstSubmitQcDate': '2018-04-10', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Valve performance', 'timeFrame': '30 days', 'description': 'effective orifice area\\<0.85 cm2/m2 and/or mean gradient\\>20 mmHg and/or aortic regurgitation\\>moderate'}, {'measure': 'Valve performance', 'timeFrame': 'one year', 'description': 'effective orifice area\\<0.85 cm2/m2 and/or mean gradient\\>20 mmHg and/or aortic regurgitation\\>moderate'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days and one year'}, {'measure': 'Patient-prosthesis mismatch', 'timeFrame': '30 days and 1 year', 'description': 'indexed effective area \\<0.65 cm2/m2'}, {'measure': 'Ellipticity index at 30 days', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bicuspid', 'TAVI', 'TAVR', 'self-expanding', 'Evolut'], 'conditions': ['Bicuspid Aortic Valve']}, 'referencesModule': {'references': [{'pmid': '30626202', 'type': 'DERIVED', 'citation': 'Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.'}]}, 'descriptionModule': {'briefSummary': 'Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.', 'detailedDescription': "Study Design Study Design: prospective non-interventional multicenter registry Screening: MSCT submitted to core lab \\& sizing strategy pre-declared (annular sizing, supra-annular sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab\n\nTAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators' discretion Study Population All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease\n\nInclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.\n\n5\\. Estimated life-expectancy\\>1 year.\n\nExclusion Criteria 1. Age \\<18 years 2. Asymptomatic patients 3. Estimated life expectancy\\<1 year 4. Pure aortic regurgitation. 5. LVEF\\<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30 days: physical examination, ECG, TTE /MSCT upon operators' judgement\n\n1 year: physical examination, ECG, TTE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years.\n2. NYHA≥2 and/or syncope and/or angina.\n3. Patient judged by the Heart Team as indicated for TAVI.\n4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.\n5. Estimated life-expectancy\\>1 year.\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Asymptomatic patients\n3. Estimated life expectancy\\<1 year\n4. Pure aortic regurgitation.\n5. LVEF\\<20%\n6. No baseline MSCT evaluation.\n7. Unsuitable aortic root anatomy for Evolut Pro or XL.\n8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.'}, 'identificationModule': {'nctId': 'NCT03495050', 'acronym': 'BIVOLUTX', 'briefTitle': 'BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Pasteur'}, 'officialTitle': 'BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.', 'orgStudyIdInfo': {'id': '2018-A00290-55'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter Aortic Valve Implantation', 'type': 'DEVICE', 'otherNames': ['Transcatheter Aortic Valve Replacement'], 'description': 'Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31076', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Didier TCHETCHE, MD', 'role': 'CONTACT', 'email': 'd.tchetche@clinique-pasteur.com', 'phone': '33562211699'}, {'name': 'Didier TCHETCEH, MD', 'role': 'CONTACT', 'email': 'd.tchetche@clinique-pasteur.com', 'phone': '33562211699'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Didier TCHETCHE, MD', 'role': 'CONTACT', 'email': 'd.tchetche@clinique-pasteur.com', 'phone': '33562211699'}, {'name': 'Didier TCHETCHE, MD', 'role': 'CONTACT', 'email': 'd.tchetche@clinique-pasteur.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Mutual ananymized database. Substudies anticipated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Pasteur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of structural heart disease program', 'investigatorFullName': 'Didier TCHETCHE', 'investigatorAffiliation': 'Clinique Pasteur'}}}}