NCT02241447

Brief Summary

The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,173

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
9 countries

23 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

Study Start

First participant enrolled

August 8, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

September 2, 2014

Last Update Submit

March 2, 2020

Conditions

Aortic Valve Stenosis

Keywords

aortic valve StenosisEchoTAVISAVRreferral

Outcome Measures

Primary Outcomes (1)

  • Referral rates at 3 months for Intervention (SAVR or TAVI)

    3 months

Secondary Outcomes (5)

  • Referral rates at 3 months for exercise testing or stress echocardiography

    3 months

  • Time to next out-patient appointment or clinical review

    15 months

  • Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)

    3 months

  • Appropriateness of treatment decisions made in collaboration with the valve specialist

    3 months

  • Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment

    3 months

Study Arms (2)

Observation

the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on

Early information

in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged over 18years identified on echocardiography with severe AS

You may qualify if:

  • Aortic valve area \< 1cm2
  • Indexed aortic valve area \<0.6 cm/m2
  • Maximum Jet velocity \> 4.0 m/sec
  • Mean transvalvular gradient \> 40 mmHg

You may not qualify if:

  • Non-severe aortic Stenosis (AS)
  • Previous aortic valve replacement (AVR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

IKEM - Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

Centre Hospitalier d'Annecy

Annecy, 74374, France

Location

Bichat Hospital

Paris, 75018, France

Location

Charité - Campus Benjamin Franklin

Berlin, 10233, Germany

Location

Herzzentrum Universitätsklinikum Köln

Cologne, 50924, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Westpfalz Klinikum

Kaiserslautern, 67655, Germany

Location

UKSK Campus Kiel, Klinik für Kardiologie und Angiologie

Kiel, 24105, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Städtisches Klinikum München

München, 80337, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Università degli Studi di Bari Aldo Moro

Bari, 70121, Italy

Location

University "Magna Græcia" of Catanzaro

Catanzaro, 88100, Italy

Location

IRCCS San Matteo Hospital

Pavia, 27100, Italy

Location

Policlinico Umberto I Rom

Rome, 00161, Italy

Location

University of Torino

Torino, Italy

Location

AMC Medical Center

Amsterdam, 1105, Netherlands

Location

Santa Creu Barcelona

Barcelona, 08025, Spain

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Bart Heart Center

London, E1 1BB, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (2)

  • Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.

    PMID: 31549578DERIVED

  • Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.

    PMID: 31302639DERIVED

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Richard Steeds, MD

    Queen Elizabeth Hospital, Birmingham, UK

    PRINCIPAL INVESTIGATOR

  • Norbert Frey, MD

    Department of Cardiology and Angiology, University of Kiel, Germany

    PRINCIPAL INVESTIGATOR

  • Davia Messika-Zeitoun, MD

    Hôpital Bichat, Paris FR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 16, 2014

Study Start

August 8, 2014

Primary Completion

May 15, 2018

Study Completion

May 31, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

FR(2)GB(3)DE(8)CZ(1)CH(1)AU(1)NL(1)ES(1)IT(5)