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

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03186339
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief 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).

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 Timeline

• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Study Start: 2017-09-08
• Primary Completion: 2019-08-15
• Study Completion: 2020-01-13
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in change in QoL between arms	3 months from baseline examination	Difference in change in QoL between the three intervention arms

Trial Locations

Locations (10)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Hospital Jacques Cartier; 🇫🇷 Massy, France

Bichat Hospital - Claude-Bernard; 🇫🇷 Paris, France

UKSH University Clinical Center Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Structual Interventional Cardiology, University Hospital Careggi; 🇮🇹 Florence, Italy

Department of Medicine, University of Verona; 🇮🇹 Verona, Italy

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Juan Canalejo Coruna; 🇪🇸 Coruna, Spain

Barts Heart Centre; 🇬🇧 London, United Kingdom