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

NCT02737150 | Unknown DMC

• 1 other identifier: 15-292
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

  30 day follow-up

• 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

  30 day follow-up

Study Arms (4)

Self-expandable valve under local anesthesia

ACTIVE COMPARATOR

CoreValve Evolut R valve under local anesthesia with conscious sedation

Device: CoreValve Evolut R; Procedure: Local anesthesia with conscious sedation

Self-expandable valve under general anesthesia

ACTIVE COMPARATOR

CoreValve Evolut R valve under general anesthesia

Device: CoreValve Evolut R; Procedure: General anesthesia

Balloon-expandable valve under local anesthesia

ACTIVE COMPARATOR

Edwards Sapien 3 valve under local anesthesia with conscious sedation

Device: Edwards Sapien 3; Procedure: Local anesthesia with conscious sedation

Balloon-expandable valve under general anesthesia

ACTIVE COMPARATOR

Edwards Sapien 3 valve under under general anesthesia

Device: Edwards Sapien 3; Procedure: General anesthesia

Interventions

CoreValve Evolut R DEVICE

Self-expandable valve under general anesthesia; Self-expandable valve under local anesthesia

Edwards Sapien 3 DEVICE

Balloon-expandable valve under general anesthesia; Balloon-expandable valve under local anesthesia

Local anesthesia with conscious sedation PROCEDURE

Balloon-expandable valve under local anesthesia; Self-expandable valve under local anesthesia

General anesthesia PROCEDURE

Balloon-expandable valve under general anesthesia; Self-expandable valve under general anesthesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Health Institute GmbH: lead
• University of Giessen: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Klinikum Links der Weser Bremen: collaborator
• University Hopsital Schleswig Holstein Campus Lübeck: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Rostock: collaborator

Study Sites (1)

University of Luebeck

Lübeck, 23538, Germany

Location

Related Publications (4)

• 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: 36434335 DERIVED

• 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: 35942626 DERIVED

• 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: 33926657 DERIVED

• 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.

  PMID: 32819145 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Anesthesia, Local; Conscious Sedation; Anesthesia, General

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

DE (1)