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

NCT02737150 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2021-02-18

No results posted yet for this study

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

Interventions

DEVICE

CoreValve Evolut R

DEVICE

Edwards Sapien 3

PROCEDURE

Local anesthesia with conscious sedation

PROCEDURE

General anesthesia

Sponsors & Collaborators

  • University of Giessen

    collaborator OTHER

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Klinikum Links der Weser Bremen

    collaborator UNKNOWN

  • University Hopsital Schleswig Holstein Campus Lübeck

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Rostock

    collaborator OTHER

  • Helios Health Institute GmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-02-01
Completion
2021-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02737150 on ClinicalTrials.gov