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Completed

NCT Number: NCT03186339

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVI

Procedure

transfemoral transcatheter aortic valve implantation

SAVR

Procedure

isolated surgical valve replacement

MM

Other

management of aortic stenosis by medical treatment only

Primary outcomes

  1. 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

  2. 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. 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

Secondary outcomes

  1. Difference in change in QoL between arms

    Time frame: 3 months from baseline examination

    Difference in change in QoL between the three intervention arms

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Acronym: TASQ

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 14, 2017
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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