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Quality of Care in AS IMPULSE Study (IMPULSE)

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ClinicalTrials.gov Identifier: NCT02241447
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Tracking Information
First Submitted Date September 2, 2014
First Posted Date September 16, 2014
Last Update Posted Date March 4, 2020
Actual Study Start Date August 8, 2014
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2014)
Referral rates at 3 months for Intervention (SAVR or TAVI) [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 12, 2014)
  • Referral rates at 3 months for exercise testing or stress echocardiography [ Time Frame: 3 months ]
  • Time to next out-patient appointment or clinical review [ Time Frame: 15 months ]
  • Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment) [ Time Frame: 3 months ]
  • Appropriateness of treatment decisions made in collaboration with the valve specialist [ Time Frame: 3 months ]
  • Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment [ Time Frame: 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults aged over 18years identified on echocardiography with severe AS
Condition Aortic Valve Stenosis
Intervention Not Provided
Study Groups/Cohorts
  • Observation
    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
  • Early information
    in this arm, 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 22, 2017)
2173
Original Estimated Enrollment
 (submitted: September 12, 2014)
800
Actual Study Completion Date May 31, 2018
Actual Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Czechia,   France,   Germany,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT02241447
Other Study ID Numbers IMPULSE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Institut für Pharmakologie und Präventive Medizin
Study Sponsor Institut für Pharmakologie und Präventive Medizin
Collaborators Edwards Lifesciences
Investigators
Principal Investigator: Richard Steeds, MD Queen Elizabeth Hospital, Birmingham, UK
Principal Investigator: Norbert Frey, MD Department of Cardiology and Angiology, University of Kiel, Germany
Principal Investigator: Davia Messika-Zeitoun, MD Hôpital Bichat, Paris FR
PRS Account Institut für Pharmakologie und Präventive Medizin
Verification Date March 2020