Aortic Valve StenosisTASQNCT03186339
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVI, SAVR and MM
- Type of treatment
- Surgery or procedure
- How many people
- 272 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 8 Sep 2017to 13 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- severe aortic stenosis
- age > 18 years
- in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve
Who cannot join
- patients not providing informed consent
- patients with major cognitive impairment
- emergency patients
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
France2 sites
Hospital Jacques Cartier
Massy, 91300
Bichat Hospital - Claude-Bernard
Paris, 75018
Italy2 sites
Structual Interventional Cardiology, University Hospital Careggi
Florence, 50134
Department of Medicine, University of Verona
Verona, 37126
Spain2 sites
Hospital Juan Canalejo Coruna
A Coruña, 15006
University Hospital Vall d'Hebron
Barcelona, 08035
Canada1 site
University Health Network, Toronto General Hospital
Toronto, Ontario, ON 5MG 2C4
Germany1 site
UKSH University Clinical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
About this study
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
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).
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVI, SAVR, MM
- Keywords
- QoL, TAVI, surgical aortic valve replacement, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVIProcedure or surgery
transfemoral transcatheter aortic valve implantation
SAVRProcedure or surgery
isolated surgical valve replacement
MMOther
management of aortic stenosis by medical treatment only
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients | patients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis Receives: Procedure: TAVI | |
| SAVR patients | patients undergoing isolated surgical valve replacement as treatment for the aortic stenosis Receives: Procedure: SAVR | |
| MM patients | patients in whom the aortic stenosis is medically managed Receives: Other: MM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months from baseline examination
Secondary outcomes (1)
Difference in change in QoL between arms
Difference in change in QoL between the three intervention arms
Measured: 3 months from baseline examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start8 Sep 2017
- Primary completion15 Aug 2019
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Rima Styra, MD, Principal investigator, University Health Network, Toronto General Hospital, Ontario, CanadaDerk Frank, Prof., Principal investigator, UKSH University Clinical Center Schleswig-Holstein, GermanySimon Kennon, MD, Principal investigator, Barts Heart Centre, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186339
- Sponsor's protocol ID
- IPPM2017TASQ
- Acronym
- TASQ
- Status last verified
- May 2022
- First submitted
- 9 Jun 2017
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31218003Frank 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.
PubMed 33207035Kennon 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.
PubMed 34810276
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03186339
- Acronym / sponsor ID
- TASQ / IPPM2017TASQ
- Conditions
- Aortic Valve Stenosis
- Keywords
- QoL, TAVI, surgical aortic valve replacement, Aortic stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | Procedure: TAVIpatients undergoing TF (transfemoral) TAVI as treatment for the aortic stenosis |
| SAVR patients | – | Procedure: SAVRpatients undergoing isolated surgical valve replacement as treatment for the aortic stenosis |
| MM patients | – | Other: MMpatients in whom the aortic stenosis is medically managed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- severe aortic stenosis
- age > 18 years
- in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve
Key exclusion criteria (3 listed)
- patients not providing informed consent
- patients with major cognitive impairment
- emergency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVItransfemoral transcatheter aortic valve implantation | Procedure or surgery | TAVI patients |
| SAVRisolated surgical valve replacement | Procedure or surgery | SAVR patients |
| MMmanagement of aortic stenosis by medical treatment only | Other | MM patients |
Primary outcome
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
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
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
1 secondary outcome
Difference in change in QoL between arms
Time frame: 3 months from baseline examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 31218003Frank 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.
- Results publication: PubMed 33207035Frank 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.
- Results publication: PubMed 34810276Kennon 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.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima Styra, MD principal investigator
University Health Network, Toronto General Hospital, Ontario, Canada
Derk Frank, Prof. principal investigator
UKSH University Clinical Center Schleswig-Holstein, Germany
Simon Kennon, MD principal investigator
Barts Heart Centre, London, UK
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Italy, Spain, Austria, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QoL as assessed by SF12 (Short Form 12) Questionnaire (time frame: 3 months from baseline examination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186339, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.