SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
NCT ID: NCT02737150
Last Updated: 2021-02-18
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
NA
444 participants
INTERVENTIONAL
2016-04-30
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Self-expandable valve under local anesthesia
CoreValve Evolut R valve under local anesthesia with conscious sedation
CoreValve Evolut R
Local anesthesia with conscious sedation
Self-expandable valve under general anesthesia
CoreValve Evolut R valve under general anesthesia
CoreValve Evolut R
General anesthesia
Balloon-expandable valve under local anesthesia
Edwards Sapien 3 valve under local anesthesia with conscious sedation
Edwards Sapien 3
Local anesthesia with conscious sedation
Balloon-expandable valve under general anesthesia
Edwards Sapien 3 valve under under general anesthesia
Edwards Sapien 3
General anesthesia
Interventions
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CoreValve Evolut R
Edwards Sapien 3
Local anesthesia with conscious sedation
General anesthesia
Eligibility Criteria
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Inclusion Criteria
* 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
* Native aortic valve annulus measuring 18-29 mm
* Suitability for transfemoral vascular access
* Written informed consent
Exclusion Criteria
* Cardiogenic shock or hemodynamic instability
* History of or active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<3 months
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for a specific mode of anesthesia as judged by the cardiac anesthesia representative of the Heart Team
* Active infection requiring antibiotic treatment
* Participation in another trial
ALL
No
Sponsors
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University of Giessen
OTHER
Heart Center Leipzig - University Hospital
OTHER
University Hospital Schleswig-Holstein
OTHER
Klinikum Links der Weser Bremen
UNKNOWN
University Hopsital Schleswig Holstein Campus Lübeck
OTHER
Charite University, Berlin, Germany
OTHER
University of Rostock
OTHER
Helios Health Institute GmbH
OTHER
Responsible Party
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Holger Thiele, MD
Director
Locations
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University of Luebeck
Lübeck, , Germany
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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15-292
Identifier Type: -
Identifier Source: org_study_id
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