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

Primary Purpose

Aortic Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CoreValve Evolut R
Edwards Sapien 3
Local anesthesia with conscious sedation
General anesthesia
Sponsored by
Helios Health Institute GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Luebeck

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Self-expandable valve under local anesthesia

Self-expandable valve under general anesthesia

Balloon-expandable valve under local anesthesia

Balloon-expandable valve under general anesthesia

Arm Description

CoreValve Evolut R valve under local anesthesia with conscious sedation

CoreValve Evolut R valve under general anesthesia

Edwards Sapien 3 valve under local anesthesia with conscious sedation

Edwards Sapien 3 valve under under general anesthesia

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Device)
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
Incidence of Treatment-Emergent Adverse Events (Anesthesia)
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

Secondary Outcome Measures

Full Information

First Posted
April 5, 2016
Last Updated
February 17, 2021
Sponsor
Helios Health Institute GmbH
Collaborators
University of Giessen, Heart Center Leipzig - University Hospital, University Hospital Schleswig-Holstein, Campus Kiel, Klinikum Links der Weser Bremen, University Hopsital Schleswig Holstein Campus Lübeck, Charite University, Berlin, Germany, University of Rostock
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1. Study Identification

Unique Protocol Identification Number
NCT02737150
Brief Title
SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI
Acronym
SOLVE-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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helios Health Institute GmbH
Collaborators
University of Giessen, Heart Center Leipzig - University Hospital, University Hospital Schleswig-Holstein, Campus Kiel, Klinikum Links der Weser Bremen, University Hopsital Schleswig Holstein Campus Lübeck, Charite University, Berlin, Germany, University of Rostock

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-expandable valve under local anesthesia
Arm Type
Active Comparator
Arm Description
CoreValve Evolut R valve under local anesthesia with conscious sedation
Arm Title
Self-expandable valve under general anesthesia
Arm Type
Active Comparator
Arm Description
CoreValve Evolut R valve under general anesthesia
Arm Title
Balloon-expandable valve under local anesthesia
Arm Type
Active Comparator
Arm Description
Edwards Sapien 3 valve under local anesthesia with conscious sedation
Arm Title
Balloon-expandable valve under general anesthesia
Arm Type
Active Comparator
Arm Description
Edwards Sapien 3 valve under under general anesthesia
Intervention Type
Device
Intervention Name(s)
CoreValve Evolut R
Intervention Type
Device
Intervention Name(s)
Edwards Sapien 3
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia with conscious sedation
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Device)
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
Time Frame
30 day follow-up
Title
Incidence of Treatment-Emergent Adverse Events (Anesthesia)
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
Time Frame
30 day follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35942626
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.
Results Reference
derived
PubMed Identifier
33926657
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.
Results Reference
derived
PubMed Identifier
32819145
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.
Results Reference
derived

Learn more about this trial

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

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