NCT03186339

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 8, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2020

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

June 9, 2017

Last Update Submit

May 13, 2022

Conditions

Aortic Valve Stenosis

Keywords

QoLTAVIsurgical aortic valve replacementAortic stenosis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Difference in change in QoL between arms

    3 months from baseline examination

Study Arms (3)

TAVI patients

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

Procedure: TAVI

SAVR patients

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

Procedure: SAVR

MM patients

patients in whom the aortic stenosis is medically managed

Other: MM

Interventions

TAVIPROCEDURE

transfemoral transcatheter aortic valve implantation

TAVI patients
SAVRPROCEDURE

isolated surgical valve replacement

SAVR patients
MMOTHER

management of aortic stenosis by medical treatment only

MM patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • severe aortic stenosis
  • age \> 18 years
  • in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve

You may not qualify if:

  • patients not providing informed consent
  • patients with major cognitive impairment
  • emergency patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Medical University of Innsbruck

Innsbruck, A-6020, Austria

Location

University Health Network, Toronto General Hospital

Toronto, Ontario, ON 5MG 2C4, Canada

Location

Hospital Jacques Cartier

Massy, 91300, France

Location

Bichat Hospital - Claude-Bernard

Paris, 75018, France

Location

UKSH University Clinical Center Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Structual Interventional Cardiology, University Hospital Careggi

Florence, 50134, Italy

Location

Department of Medicine, University of Verona

Verona, 37126, Italy

Location

Hospital Juan Canalejo Coruna

A Coruña, 15006, Spain

Location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Barts Heart Centre

London, EC1A7BE, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 31218003BACKGROUND

  • 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.

    PMID: 33207035RESULT

  • 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.

    PMID: 34810276RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

September 8, 2017

Primary Completion

August 15, 2019

Study Completion

January 13, 2020

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)AU(1)ES(2)CA(1)FR(2)IT(2)DE(1)