Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
NCT ID: NCT03186339
Last Updated: 2022-05-18
Study Results
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Basic Information
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COMPLETED
272 participants
OBSERVATIONAL
2017-09-08
2020-01-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TAVI patients
patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis
TAVI
transfemoral transcatheter aortic valve implantation
SAVR patients
patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis
SAVR
isolated surgical valve replacement
MM patients
patients in whom the aortic stenosis is medically managed
MM
management of aortic stenosis by medical treatment only
Interventions
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TAVI
transfemoral transcatheter aortic valve implantation
SAVR
isolated surgical valve replacement
MM
management of aortic stenosis by medical treatment only
Eligibility Criteria
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Inclusion Criteria
* age \> 18 years
* in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve
Exclusion Criteria
* patients with major cognitive impairment
* emergency patients
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Rima Styra, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto General Hospital, Ontario, Canada
Derk Frank, Prof.
Role: PRINCIPAL_INVESTIGATOR
UKSH University Clinical Center Schleswig-Holstein, Germany
Simon Kennon, MD
Role: PRINCIPAL_INVESTIGATOR
Barts Heart Centre, London, UK
Locations
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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
Hospital Juan Canalejo Coruna
A Coruña, , Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
Barts Heart Centre
London, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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IPPM2017TASQ
Identifier Type: -
Identifier Source: org_study_id
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