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Quality of Care in AS IMPULSE Study (IMPULSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease
Aortic Valve Stenosis

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2173 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry
Actual Study Start Date : August 8, 2014
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Referral rates at 3 months for Intervention (SAVR or TAVI) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged over 18years identified on echocardiography with severe AS
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241447


Locations
Show Show 23 study locations
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02241447    
Other Study ID Numbers: IMPULSE
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
aortic valve Stenosis
Echo
TAVI
SAVR
referral
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction