Brief Title
Quality of Care in AS IMPULSE Study
Official Title
Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
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.
Detailed Description
All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, 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. There will also be an optional telephone follow-up to find out the patient's outcome. Intervention: In this phase, 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. Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented. Observation B: Same as Observation Phase A
Study Type
Observational [Patient Registry]
Primary Outcome
Referral rates at 3 months for Intervention (SAVR or TAVI)
Secondary Outcome
Referral rates at 3 months for exercise testing or stress echocardiography
Condition
Aortic Valve Stenosis
Study Arms / Comparison Groups
Observation
Description: 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
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
2173
Start Date
August 8, 2014
Completion Date
May 31, 2018
Primary Completion Date
May 15, 2018
Eligibility Criteria
Inclusion Criteria: - Aortic valve area < 1cm2 - Indexed aortic valve area <0.6 cm/m2 - Maximum Jet velocity > 4.0 m/sec - Mean transvalvular gradient > 40 mmHg Exclusion Criteria: - Non-severe aortic Stenosis (AS) - Previous aortic valve replacement (AVR)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Richard Steeds, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02241447
Organization ID
IMPULSE
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Collaborators
Edwards Lifesciences
Study Sponsor
Richard Steeds, MD, Principal Investigator, Queen Elizabeth Hospital, Birmingham, UK
Verification Date
March 2020