Brief Title
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Official Title
CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Incidence of Treatment-Emergent Adverse Events (Device)
Condition
Aortic Stenosis
Intervention
CoreValve Evolut R
Study Arms / Comparison Groups
Self-expandable valve under local anesthesia
Description: CoreValve Evolut R valve under local anesthesia with conscious sedation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
444
Start Date
April 2016
Completion Date
April 2021
Primary Completion Date
February 1, 2019
Eligibility Criteria
Inclusion Criteria: - Severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm²/m² - 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: - Life expectancy <12 months due to comorbidities - 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02737150
Organization ID
15-292
Responsible Party
Principal Investigator
Study Sponsor
Leipzig Heart Institute GmbH
Collaborators
University of Giessen
Study Sponsor
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Verification Date
February 2021