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Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI

NCT03186339 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2022-05-18

No results posted yet for this study

Summary

Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

TAVI

transfemoral transcatheter aortic valve implantation

PROCEDURE

SAVR

isolated surgical valve replacement

OTHER

MM

management of aortic stenosis by medical treatment only

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Rima Styra, MD · University Health Network, Toronto General Hospital, Ontario, Canada

  • Derk Frank, Prof. · UKSH University Clinical Center Schleswig-Holstein, Germany

  • Simon Kennon, MD · Barts Heart Centre, London, UK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2019-08-15
Completion
2020-01-13

Countries

  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT03186339 on ClinicalTrials.gov