Quality of Care in AS IMPULSE Study

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

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