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Quality of Care in AS IMPULSE Study

Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02241447
Acronym
IMPULSE
Enrollment
2173
Registered
2014-09-16
Start date
2014-08-08
Completion date
2018-05-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

aortic valve Stenosis, Echo, TAVI, SAVR, referral

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

Interventions

None listed

Sponsors

Edwards Lifesciences
CollaboratorINDUSTRY
Institut für Pharmakologie und Präventive Medizin
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment3 months
Referral rates at 3 months for exercise testing or stress echocardiography3 months
Time to next out-patient appointment or clinical review15 months
Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)3 months
Appropriateness of treatment decisions made in collaboration with the valve specialist3 months

Countries

Austria, Czechia, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026