Clinical trial NCT03186339: Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: QoL
TAVI
surgical aortic valve replacement
Aortic stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2017-06-14
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in QoL as assessed by SF12 (Short Form 12) Questionnaire
timeFrame: 3 months from baseline examination
measure: Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire)
timeFrame: 3 months from baseline examination
measure: Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire)
timeFrame: 3 months from baseline examination
Secondary outcomes:
measure: Difference in change in QoL between arms
timeFrame: 3 months from baseline examination
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
state: Ontario
city: Massy
country: France
facility: Hospital Jacques Cartier
city: Paris
country: France
facility: Bichat Hospital - Claude-Bernard
city: Kiel
country: Germany
facility: UKSH University Clinical Center Schleswig-Holstein
state: Schleswig-Holstein
city: Florence
country: Italy
facility: Structual Interventional Cardiology, University Hospital Careggi
city: Verona
country: Italy
facility: Department of Medicine, University of Verona
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Coruna
country: Spain
facility: Hospital Juan Canalejo Coruna
city: London
country: United Kingdom
facility: Barts Heart Centre
Study officials:
affiliation: University Health Network, Toronto General Hospital, Ontario, Canada
name: Rima Styra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UKSH University Clinical Center Schleswig-Holstein, Germany
name: Derk Frank, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Barts Heart Centre, London, UK
name: Simon Kennon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frank D, Kennon S, Bonaros N, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Kurucova J, Thoenes M, Luske 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.
citation: Frank D, Kennon S, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano 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, Luske CM, Bramlage P, Styra R. Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire. ESC Heart Fail. 2021 Feb;8(1):270-279. doi: 10.1002/ehf2.12961. Epub 2020 Nov 18.
citation: Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2):e001821. doi: 10.1136/openhrt-2021-001821.