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

Aortic Valve Stenosis Clinical Trial

— TASQ  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186339
• Other study ID #: IPPM2017TASQ
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: January 13, 2020

Study information

• Verified date: May 2022
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: January 13, 2020
• Est. primary completion date: August 15, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Procedure:
• TAVI
transfemoral transcatheter aortic valve implantation
• SAVR
isolated surgical valve replacement

Other:
• MM
management of aortic stenosis by medical treatment only

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
France	Hospital Jacques Cartier	Massy
France	Bichat Hospital - Claude-Bernard	Paris
Germany	UKSH University Clinical Center Schleswig-Holstein	Kiel	Schleswig-Holstein
Italy	Structual Interventional Cardiology, University Hospital Careggi	Florence
Italy	Department of Medicine, University of Verona	Verona
Spain	University Hospital Vall d'Hebron	Barcelona
Spain	Hospital Juan Canalejo Coruna	Coruna
United Kingdom	Barts Heart Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

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

References & Publications (3)

Frank D, Kennon S, Bonaros N, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Kurucova J, Thoenes M, Lüske C, Bramlage P, Styra R. Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry. Open Heart. 2019 May 21;6(1):e001008. doi: 10.1136/openhrt-2019-001008. eCollection 2019. — View Citation

Frank D, Kennon S, Bonaros N, Stastny L, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini F, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Castillo JJC, Garcia Del Blanco B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Lüske CM, Bramlage P, Styra — View Citation

Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Lüske C, Bramlage P, Frank D. Q — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QoL as assessed by SF12 (Short Form 12) Questionnaire	Change in quality of life as assessed by the SF12 using a points system	3 months from baseline examination
Primary	Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire)	Change in quality of life as assessed by the KCCQ using a points system	3 months from baseline examination
Primary	Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire)	Change in quality of life as assessed by the TASQ using a points system	3 months from baseline examination
Secondary	Difference in change in QoL between arms	Difference in change in QoL between the three intervention arms	3 months from baseline examination