Brief Title
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
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 Type
Observational
Primary Outcome
Change in QoL as assessed by SF12 (Short Form 12) Questionnaire
Secondary Outcome
Difference in change in QoL between arms
Condition
Aortic Valve Stenosis
Intervention
TAVI
Study Arms / Comparison Groups
TAVI patients
Description: patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
272
Start Date
September 8, 2017
Completion Date
January 13, 2020
Primary Completion Date
August 15, 2019
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
Gender
All
Ages
18 Years - N/A
Contacts
Rima Styra, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03186339
Organization ID
IPPM2017TASQ
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Edwards Lifesciences
Study Sponsor
Rima Styra, MD, Principal Investigator, University Health Network, Toronto General Hospital, Ontario, Canada
Verification Date
February 2020