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

Institut für Pharmakologie und Präventive Medizin

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: TAVI; Procedure: SAVR; Other: MM

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT03186339

IPPM2017TASQ

Details and patient eligibility

About

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).

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

272 participants in 3 patient groups

TAVI patients

Description:

patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis

Treatment:

Procedure: TAVI

SAVR patients

Description:

patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis

Treatment:

Procedure: SAVR

MM patients

Description:

patients in whom the aortic stenosis is medically managed

Treatment:

Other: MM