Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVI patients | patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis |
| |
| SAVR patients | patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis |
| |
| MM patients | patients in whom the aortic stenosis is medically managed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI | Procedure | transfemoral transcatheter aortic valve implantation |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rima Styra, MD | University Health Network, Toronto General Hospital, Ontario, Canada | Principal Investigator |
| Derk Frank, Prof. | UKSH University Clinical Center Schleswig-Holstein, Germany | Principal Investigator |
| Simon Kennon, MD | Barts Heart Centre, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | A-6020 | Austria | |||
| University Health Network, Toronto General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31218003 | Background | 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. | |
| 33207035 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| SAVR |
| Procedure |
isolated surgical valve replacement |
|
| MM | Other | management of aortic stenosis by medical treatment only |
|
| Toronto |
| Ontario |
| ON 5MG 2C4 |
| Canada |
| Hospital Jacques Cartier | Massy | 91300 | France |
| Bichat Hospital - Claude-Bernard | Paris | 75018 | France |
| UKSH University Clinical Center Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Structual Interventional Cardiology, University Hospital Careggi | Florence | 50134 | Italy |
| Department of Medicine, University of Verona | Verona | 37126 | Italy |
| Hospital Juan Canalejo Coruna | A Coruña | 15006 | Spain |
| University Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Barts Heart Centre | London | EC1A7BE | United Kingdom |
| Result |
| 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. |
| 34810276 | Result | 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. |
| D014694 |
| Ventricular Outflow Obstruction |