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Study to Improve Outcomes in Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT03112629
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief Summary:

Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions).

The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.


Condition or disease
Aortic Valve Stenosis

Detailed Description:

Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access.

The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
symptomatic AS
Patients diagnosed with severe aortic stenosis in echocardiography who display one or more of the following symptoms: exertional shortness of breath, chest pain, exertional dizziness or syncope.
asymptomatic AS
Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms



Primary Outcome Measures :
  1. Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals [ Time Frame: 12 months ]
    The purpose of this study is to determine treatment pathways for patients with severe AS and to find out about the critical steps in this pathway with respect to the time-course and treatment decisions made.


Secondary Outcome Measures :
  1. Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope) [ Time Frame: 12 months ]
    Time course for the transition from asymptomatic in symptomatic severe AS and analysis of multivariables predictors for the development of symptoms (based on echo data and comorbidities at baseline)

  2. Outcomes (survival) (intervention vs. conservative treatment) [ Time Frame: 12 months ]
    rates of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults aged over 18years identified on echocardiography with severe AS (irrespective of symptoms).
Criteria

Inclusion Criteria:

  • age over 18 years
  • identified on echocardiography with severe aortic stenosis, defined as at least one of:
  • aortic valve area < 1 cm2
  • indexed valve area < 0.6 cm2/m2
  • maximum jet velocity > 4.0 m/sec
  • mean transvalvular gradient > 40 mmHg

Exclusion Criteria:

  • non-severe aortic stenosis
  • previous aortic valve repair

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): NCT03112629


Contacts
Contact: Peter Bramlage, Prof +49(0)3379-3147890 peter.bramlage@ippmed.de
Contact: Christiane Pohlmann +49(0)44718503328 christiane.pohlmann@ippmed.de

Locations
France
Bichat Hospital Paris Recruiting
Paris, France, 75018
Contact: David Messika-Zeitoun, Prof       david.messika-zeitoun@bch.aphp.fr   
Principal Investigator: David Messika-Zeitoun, Prof         
Germany
Department of Cardiology and Angiology, University of Kiel Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Norbert Frey, Prof    +49(0)43150022801    norbert.frey@uksh.de   
Principal Investigator: Norbert Frey, Prof         
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
Study Chair: Stephan Balduss, Prof University of Cologne
Study Chair: Norbert Frey, Prof University of Kiel, Germany
Study Chair: Richard Steeds, Prof Queen Elizabeth Hospital, Birmingham, UK
Study Chair: David Messika-Zeitoun, Prof Bichat Hospital, Paris, France

Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03112629     History of Changes
Other Study ID Numbers: Impulse enhanced
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing of individual patient data is planned

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:
Quality of Care
aortic stenosis
transcatheter aortic valve implantation
surgical aortic valve replacement
facilitated data relay

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction