Clinical trial NCT03112629: Study to Improve Outcomes in Aortic Stenosis
Official title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Quality of Care
aortic stenosis
transcatheter aortic valve implantation
surgical aortic valve replacement
facilitated data relay
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2017-04-13
Enrollment: 791
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).

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.

Detailed description: Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access.

The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* non-severe aortic stenosis
* previous aortic valve repair

Primary outcomes:
measure: Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals
timeFrame: 12 months
Secondary outcomes:
measure: Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)
timeFrame: 12 months
measure: Outcomes (survival) (intervention vs. conservative treatment)
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital Paris
city: Kiel
country: Germany
facility: Department of Cardiology and Angiology, University of Kiel
state: Schleswig-Holstein
Study officials:
affiliation: University of Cologne
name: Stephan Balduss, Prof
role: STUDY_CHAIR
affiliation: University of Kiel, Germany
name: Norbert Frey, Prof
role: STUDY_CHAIR
affiliation: Queen Elizabeth Hospital, Birmingham, UK
name: Richard Steeds, Prof
role: STUDY_CHAIR
affiliation: Bichat Hospital, Paris, France
name: David Messika-Zeitoun, Prof
role: STUDY_CHAIR
References:
citation: 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.