Study to Improve Outcomes in Aortic Stenosis
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03112629|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : August 9, 2018
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|
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|
|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|
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.
Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms
- 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.
- 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)
- Outcomes (survival) (intervention vs. conservative treatment) [ Time Frame: 12 months ]rates of death
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
|Contact: Peter Bramlage, Prof||+49(0)firstname.lastname@example.org|
|Contact: Christiane Pohlmann||+49(0)email@example.com|
|Bichat Hospital Paris||Recruiting|
|Paris, France, 75018|
|Contact: David Messika-Zeitoun, Prof firstname.lastname@example.org|
|Principal Investigator: David Messika-Zeitoun, Prof|
|Department of Cardiology and Angiology, University of Kiel||Not yet recruiting|
|Kiel, Schleswig-Holstein, Germany, 24105|
|Contact: Norbert Frey, Prof +49(0)43150022801 email@example.com|
|Principal Investigator: Norbert Frey, Prof|
|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|