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SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI (SOLVE-TAVI)

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ClinicalTrials.gov Identifier: NCT02737150
Recruitment Status : Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
University of Giessen
Heart Center Leipzig - University Hospital
University Hospital Schleswig-Holstein, Campus Kiel
Klinikum Links der Weser Bremen
University of Schleswig-Holstein, Campus Lübeck
Charite University, Berlin, Germany
University of Rostock
Information provided by (Responsible Party):
Holger Thiele, MD, Heart Center Leipzig - University Hospital

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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: CoreValve Evolut R Device: Edwards Sapien 3 Procedure: Local anesthesia with conscious sedation Procedure: General anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)
Study Start Date : April 2016
Actual Primary Completion Date : February 1, 2019
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Self-expandable valve under local anesthesia
CoreValve Evolut R valve under local anesthesia with conscious sedation
Device: CoreValve Evolut R
Procedure: Local anesthesia with conscious sedation
Active Comparator: Self-expandable valve under general anesthesia
CoreValve Evolut R valve under general anesthesia
Device: CoreValve Evolut R
Procedure: General anesthesia
Active Comparator: Balloon-expandable valve under local anesthesia
Edwards Sapien 3 valve under local anesthesia with conscious sedation
Device: Edwards Sapien 3
Procedure: Local anesthesia with conscious sedation
Active Comparator: Balloon-expandable valve under general anesthesia
Edwards Sapien 3 valve under under general anesthesia
Device: Edwards Sapien 3
Procedure: General anesthesia



Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (Device) [ Time Frame: 30 day follow-up ]
    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

  2. Incidence of Treatment-Emergent Adverse Events (Anesthesia) [ Time Frame: 30 day follow-up ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737150


Locations
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Germany
University of Luebeck
Luebeck, Germany, 23538
Sponsors and Collaborators
Leipzig Heart Institute GmbH
University of Giessen
Heart Center Leipzig - University Hospital
University Hospital Schleswig-Holstein, Campus Kiel
Klinikum Links der Weser Bremen
University of Schleswig-Holstein, Campus Lübeck
Charite University, Berlin, Germany
University of Rostock

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Responsible Party: Holger Thiele, MD, Director, Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT02737150     History of Changes
Other Study ID Numbers: 15-292
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs