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

May 13, 2022 updated by: Institut für Pharmakologie und Präventive Medizin

Validation of the "Toronto Aortic Stenosis Quality of Life Questionnaire" in Patients Undergoing Surgical Aortic Valve Replacement or Transfemoral Transcatheter Aortic Valve Implantation The TASQ Registry

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Currently, there are two cardiovascular disease QoL scales which have been used in studies of patients with aortic stenosis - the Minnesota Living with Heart Failure (MLHF) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ).

The KCCQ has now become the only cited health related (HR) QoL validated scale for use among a growing TAVI (Transcatheter Aortic Valve Implantation) patient population; however questions on the KCCQ do not reflect the concerns and lifestyle of patients proceeding for aortic valve intervention. Many of the questions do not reflect this patient population's perspective of well-being in contrast to perceptions by the general cardiac population on which it was validated. It is important to capture the disruptions caused by a chronic disease and its treatment on lifestyles, activities, and interests; that is interference with psychologically meaningful activity. It has been noted that this interference varies by disease process and treatment by general scales such as the Illness Intrusiveness Scale .

Due to issues of limited validity of the KCCQ for TAVI / SAVR (Surgical Aortic Valve Replacement) patients related to symptom items not being revised from their original use for congestive heart failure, a new original HR-QoL questionnaire was proposed: The "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) is a health specific measurement tool designed to measure changes in quality of life in aortic stenosis patients. The aim of this study is to validate this questionnaire in this specific patient population.

Study Type

Observational

Enrollment (Actual)

272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Medical University of Innsbruck
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, ON 5MG 2C4
        • University Health Network, Toronto General Hospital
  • France
      • Massy, France, 91300
        • Hospital Jacques Cartier
      • Paris, France, 75018
        • Bichat Hospital - Claude-Bernard
  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • UKSH University Clinical Center Schleswig-Holstein
  • Italy
      • Florence, Italy, 50134
        • Structual Interventional Cardiology, University Hospital Careggi
      • Verona, Italy, 37126
        • Department of Medicine, University of Verona
  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
      • Coruna, Spain, 15006
        • Hospital Juan Canalejo Coruna
  • United Kingdom
      • London, United Kingdom, EC1A7BE
        • Barts Heart Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

120 consecutive patients undergoing TF-TAVI, 120 patients undergoing SAVR, and a control group of 50 patients receiving medical treatment will be enrolled. Because of an expected loss during follow-up with not all patients returning this will result in about 100 patients for both TAVI and SAVR and 40 for medical management or 48 per language.

Description

Inclusion Criteria:

  • severe aortic stenosis
  • age > 18 years
  • in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve

Exclusion Criteria:

  • patients not providing informed consent
  • patients with major cognitive impairment
  • emergency patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAVI patients
patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis
Procedure: TAVI
transfemoral transcatheter aortic valve implantation
SAVR patients
patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis
Procedure: SAVR
isolated surgical valve replacement
MM patients
patients in whom the aortic stenosis is medically managed
Other: MM
management of aortic stenosis by medical treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QoL as assessed by SF12 (Short Form 12) Questionnaire
Time Frame: 3 months from baseline examination
Change in quality of life as assessed by the SF12 using a points system
3 months from baseline examination
Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Time Frame: 3 months from baseline examination
Change in quality of life as assessed by the KCCQ using a points system
3 months from baseline examination
Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire)
Time Frame: 3 months from baseline examination
Change in quality of life as assessed by the TASQ using a points system
3 months from baseline examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change in QoL between arms
Time Frame: 3 months from baseline examination
Difference in change in QoL between the three intervention arms
3 months from baseline examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pharmakologie und Präventive Medizin

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Rima Styra, MD, University Health Network, Toronto General Hospital, Ontario, Canada
  • Principal Investigator: Derk Frank, Prof., UKSH University Clinical Center Schleswig-Holstein, Germany
  • Principal Investigator: Simon Kennon, MD, Barts Heart Centre, London, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2017

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

January 13, 2020

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPPM2017TASQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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