ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03186339
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

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).

Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: TAVI Procedure: SAVR Other: MM

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
Estimated Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAVI patients
patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis
Procedure: TAVI
transfemoral transcatheter aortic valve implantation

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

MM patients
patients in whom the aortic stenosis is medically managed
Other: MM
management of aortic stenosis by medical treatment only




Primary Outcome Measures :
  1. Change in QoL as assessed by SF12 (Short Form 12) Questionnaire [ Time Frame: 3 months from baseline examination ]
    Change in quality of life as assessed by the SF12 using a points system

  2. Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire) [ Time Frame: 3 months from baseline examination ]
    Change in quality of life as assessed by the KCCQ using a points system

  3. Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire) [ Time Frame: 3 months from baseline examination ]
    Change in quality of life as assessed by the TASQ using a points system


Secondary Outcome Measures :
  1. Difference in change in QoL between arms [ Time Frame: 3 months from baseline examination ]
    Difference in change in QoL between the three intervention arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186339


Contacts
Contact: Peter Bramlage, Prof +49(0)3379-3147890 peter.bramlage@ippmed.de
Contact: Claudia Lueske, PhD +4944718503324 claudia.lueske@ippmed.de

Locations
Austria
Medical University of Innsbruck Recruiting
Innsbruck, Austria, A-6020
Contact: Nikolaos Bonaros, Prof.    +4351250480764    nikolaos.bonaros@tirol-kliniken.at   
Principal Investigator: Nikolaos Bonaros, Prof.         
Canada, Ontario
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, ON 5MG 2C4
Contact: Rima Styra, MD    +1 416-340-4825    rima.styra@uhn.ca   
Principal Investigator: Rima Styra, MD         
France
Hospital Jacques Cartier Recruiting
Massy, France, 91300
Contact: Mauro Romano, MD    01 69 20 89 16    romano.mauro@orange.fr   
Contact: Thierry Lefevre, MD    01 69 20 89 16    t.lefevre@angio-icps.com   
Principal Investigator: Mauro Romano, MD         
Principal Investigator: Thierry Lefevre, MD         
Bichat Hospital - Claude-Bernard Recruiting
Paris, France, 75018
Contact: Dominique Himbert, MD    01 40 25 66 01    dominique.himbert@aphp.fr   
Contact: Marina Urena-Alcazar, MD    01 40 25 66 01    marina.urena-alcazar@aphp.fr   
Principal Investigator: Dominique Himbert, MD         
Principal Investigator: Marina Urena-Alcazar, MD         
Germany
UKSH University Clinical Center Schleswig-Holstein Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Derk Frank, Prof.    +49 431 500-22812    derk.frank@uksh.de   
Principal Investigator: Derk Frank, Prof         
Italy
Structual Interventional Cardiology, University Hospital Careggi Recruiting
Florence, Italy, 50134
Contact: Carlo Di Mario, MD       carlo.dimario@unifi.it   
Contact: Pierluigi Stefano, MD       stefanop@aou-careggi.toscana.it   
Principal Investigator: carlo Di Mario, MD         
Principal Investigator: Pierluigi Stefano, MD         
Department of Medicine, University of Verona Recruiting
Verona, Italy, 37126
Contact: Flavio Ribichini, Prof.    0458122320    flavio.ribichini@univr.it   
Principal Investigator: Flavio Ribichini, Prof.         
Spain
University Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Bruno Garcia, MD    93 274 61 55    brunogb51@gmail.com   
Contact: Carlos Sureda, MD       carlossureda@gmail.com   
Principal Investigator: Bruno Garcia, MD         
Sub-Investigator: Carlos Sureda, MD         
Hospital Juan Canalejo Coruna Recruiting
Coruna, Spain, 15006
Contact: Jorge Salgado, MD    981178000    jorge.salgado.fernandez@sergas.es   
Contact: Cuenca Castillo, MD       josecuenca@cardiocrunia.e.telefonica.net   
Principal Investigator: Jorge Salgado, MD         
Sub-Investigator: Cuenca Castillo, MD         
United Kingdom
Barts Heart Centre Recruiting
London, United Kingdom, EC1A7BE
Contact: Simon Kennon, MD    +44 20 3765 8639    simon.kennon@bartshealth.nhs.uk   
Principal Investigator: Simon Kennon, MD         
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
Principal Investigator: 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

Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03186339     History of Changes
Other Study ID Numbers: IPPM2017TASQ
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut für Pharmakologie und Präventive Medizin:
QoL
TAVI
surgical aortic valve replacement
Aortic stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction