Brief Title
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
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals
Secondary Outcome
Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)
Condition
Aortic Valve Stenosis
Study Arms / Comparison Groups
symptomatic AS
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
791
Start Date
March 23, 2017
Completion Date
April 3, 2019
Primary Completion Date
March 12, 2019
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
Gender
All
Ages
18 Years - N/A
Contacts
Stephan Balduss, Prof, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03112629
Organization ID
Impulse enhanced
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Edwards Lifesciences
Study Sponsor
Stephan Balduss, Prof, Study Chair, University of Cologne
Verification Date
February 2020