Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-29 @ 3:31 PM
Study NCT ID:
NCT02737150
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D016292', 'term': 'Conscious Sedation'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-09', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Device)', 'timeFrame': '30 day follow-up', 'description': 'Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (Anesthesia)', 'timeFrame': '30 day follow-up', 'description': 'Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'referencesModule': {'references': [{'pmid': '36434335', 'type': 'DERIVED', 'citation': 'Stachel G, Abdel-Wahab M, de Waha-Thiele S, Desch S, Feistritzer HJ, Kitamura M, Farhan S, Eitel I, Kurz T, Thiele H. Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation. Int J Cardiovasc Imaging. 2022 Nov;38(11):2469-2478. doi: 10.1007/s10554-022-02657-1. Epub 2022 Jun 24.'}, {'pmid': '35942626', 'type': 'DERIVED', 'citation': 'Farhan S, Stachel G, Desch S, Kurz T, Feistritzer HJ, Hartung P, Eitel I, Nef H, Doerr O, Lauten A, Landmesser U, Sandri M, Holzhey D, Borger M, Ince H, Oner A, Meyer-Saraei R, Wienbergen H, Fach A, Frey N, de Waha-Thiele S, Thiele H. Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial. EuroIntervention. 2022 Oct 21;18(9):759-768. doi: 10.4244/EIJ-D-22-00156.'}, {'pmid': '33926657', 'type': 'DERIVED', 'citation': 'Feistritzer HJ, Kurz T, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Wienbergen H, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Funkat AK, Berggreen AE, Heringlake M, Desch S, de Waha-Thiele S, Thiele H; SOLVE-TAVI Investigators. Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2021 May 4;77(17):2204-2215. doi: 10.1016/j.jacc.2021.03.007.'}, {'pmid': '32819145', 'type': 'DERIVED', 'citation': 'Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Ruckert Y, Funkat AK, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation. 2020 Oct 13;142(15):1437-1447. doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m²\n* Age ≥75 years and/or logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥20% and/or Society of Thoracic Surgeons (STS) risk score ≥10% and/or high risk/contraindication to conventional surgical aortic valve replacement\n* Native aortic valve annulus measuring 18-29 mm\n* Suitability for transfemoral vascular access\n* Written informed consent\n\nExclusion Criteria:\n\n* Life expectancy \\<12 months due to comorbidities\n* Cardiogenic shock or hemodynamic instability\n* History of or active endocarditis\n* Contraindications for transfemoral access\n* Active peptic ulcer or upper gastro-intestinal bleeding \\<3 months\n* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel\n* Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team\n* Active infection requiring antibiotic treatment\n* Participation in another trial'}, 'identificationModule': {'nctId': 'NCT02737150', 'acronym': 'SOLVE-TAVI', 'briefTitle': 'SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Helios Health Institute GmbH'}, 'officialTitle': 'CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)', 'orgStudyIdInfo': {'id': '15-292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-expandable valve under local anesthesia', 'description': 'CoreValve Evolut R valve under local anesthesia with conscious sedation', 'interventionNames': ['Device: CoreValve Evolut R', 'Procedure: Local anesthesia with conscious sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-expandable valve under general anesthesia', 'description': 'CoreValve Evolut R valve under general anesthesia', 'interventionNames': ['Device: CoreValve Evolut R', 'Procedure: General anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balloon-expandable valve under local anesthesia', 'description': 'Edwards Sapien 3 valve under local anesthesia with conscious sedation', 'interventionNames': ['Device: Edwards Sapien 3', 'Procedure: Local anesthesia with conscious sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balloon-expandable valve under general anesthesia', 'description': 'Edwards Sapien 3 valve under under general anesthesia', 'interventionNames': ['Device: Edwards Sapien 3', 'Procedure: General anesthesia']}], 'interventions': [{'name': 'CoreValve Evolut R', 'type': 'DEVICE', 'armGroupLabels': ['Self-expandable valve under general anesthesia', 'Self-expandable valve under local anesthesia']}, {'name': 'Edwards Sapien 3', 'type': 'DEVICE', 'armGroupLabels': ['Balloon-expandable valve under general anesthesia', 'Balloon-expandable valve under local anesthesia']}, {'name': 'Local anesthesia with conscious sedation', 'type': 'PROCEDURE', 'armGroupLabels': ['Balloon-expandable valve under local anesthesia', 'Self-expandable valve under local anesthesia']}, {'name': 'General anesthesia', 'type': 'PROCEDURE', 'armGroupLabels': ['Balloon-expandable valve under general anesthesia', 'Self-expandable valve under general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Health Institute GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Giessen', 'class': 'OTHER'}, {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, {'name': 'Klinikum Links der Weser Bremen', 'class': 'UNKNOWN'}, {'name': 'University Hopsital Schleswig Holstein Campus Lübeck', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'University of Rostock', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Holger Thiele, MD', 'investigatorAffiliation': 'Heart Center Leipzig - University Hospital'}}}}