Study to Improve Outcomes in Aortic Stenosis

NCT03112629 | Completed

• 1 other identifier: Impulse enhanced
• Study Type: observational
• Target: 791
• Locations: 2 countries
• Sites: 2

Brief Summary

Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions). The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.

Conditions

Aortic Valve Stenosis

Keywords

Quality of Care; aortic stenosis; transcatheter aortic valve implantation; surgical aortic valve replacement; facilitated data relay

Outcome Measures

Primary Outcomes (1)

• Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals

  The purpose of this study is to determine treatment pathways for patients with severe AS and to find out about the critical steps in this pathway with respect to the time-course and treatment decisions made.

  12 months

Secondary Outcomes (2)

• Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)

  12 months

• Outcomes (survival) (intervention vs. conservative treatment)

  12 months

Study Arms (2)

symptomatic AS

Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope.

asymptomatic AS

Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).

You may qualify if:

• age over 18 years
• identified on echocardiography with severe aortic stenosis, defined as at least one of:
• aortic valve area \< 1 cm2
• indexed valve area \< 0.6 cm2/m2
• maximum jet velocity \> 4.0 m/sec
• mean transvalvular gradient \> 40 mmHg

You may not qualify if:

• non-severe aortic stenosis
• previous aortic valve repair

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (2)

Bichat Hospital Paris

Paris, 75018, France

Location

Department of Cardiology and Angiology, University of Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (2)

• Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Steeds RP; IMPULSE enhanced investigators. Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres. Heart. 2023 May 26;109(12):944-950. doi: 10.1136/heartjnl-2022-321566.

  PMID: 36657962 DERIVED

• Rudolph TK, Messika-Zeitoun D, Frey N, Lutz M, Krapf L, Passefort S, Fryearson J, Simpson H, Mortensen K, Rehse S, Tiroke A, Dodos F, Mies F, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Steeds RP. Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry. Open Heart. 2019 Jul 21;6(2):e001019. doi: 10.1136/openhrt-2019-001019. eCollection 2019.

  PMID: 31413844 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Stephan Balduss, Prof

  University of Cologne

  STUDY CHAIR

• Norbert Frey, Prof

  University of Kiel, Germany

  STUDY CHAIR

• Richard Steeds, Prof

  Queen Elizabeth Hospital, Birmingham, UK

  STUDY CHAIR

• David Messika-Zeitoun, Prof

  Bichat Hospital, Paris, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 13, 2017
• Study Start: March 23, 2017
• Primary Completion: March 12, 2019
• Study Completion: April 3, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1)