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Completed

NCT Number: NCT02241447

Quality of Care in AS IMPULSE Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Hietzing, Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Referral rates at 3 months for Intervention (SAVR or TAVI)

    Time frame: 3 months

Secondary outcomes

  1. Referral rates at 3 months for exercise testing or stress echocardiography

    Time frame: 3 months

  2. Time to next out-patient appointment or clinical review

    Time frame: 15 months

  3. Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)

    Time frame: 3 months

  4. Appropriateness of treatment decisions made in collaboration with the valve specialist

    Time frame: 3 months

  5. Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

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

Acronym: IMPULSE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2014
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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