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

Study Overview
=================
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.

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

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Procedure: TAVI
* Procedure: SAVR
* Other: MM


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI patients<br>patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis | Procedure: TAVI<br>* transfemoral transcatheter aortic valve implantation<br>|
| SAVR patients<br>patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis | Procedure: SAVR<br>* isolated surgical valve replacement<br>|
| MM patients<br>patients in whom the aortic stenosis is medically managed | Other: MM<br>* management of aortic stenosis by medical treatment only<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in QoL between arms | Difference in change in QoL between the three intervention arms | 3 months from baseline examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QoL, TAVI, surgical aortic valve replacement, Aortic stenosis