Clinical Trial: Study to Improve Outcomes in Aortic Stenosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: IMPULSE Enhanced - Study to Improve Outcomes in Aortic Stenosis - International, Multi-centre, Prospective, Observational Cohort Study

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.


Detailed Summary:

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.


Sponsor: Institut für Pharmakologie und Präventive Medizin

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Institut für Pharmakologie und Präventive Medizin

Dates:
Date Received: March 21, 2017
Date Started: April 30, 2017
Date Completion: June 30, 2019
Last Updated: April 7, 2017
Last Verified: April 2017