Clinical Trials Directory

Trials / Completed

CompletedNCT03112629

Study to Improve Outcomes in Aortic Stenosis

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

Status
Completed
Phase
Study type
Observational
Enrollment
791 (actual)
Sponsor
Institut für Pharmakologie und Präventive Medizin · Network
Sex
All
Age
18 Years
Healthy volunteers

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 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.

Conditions

Timeline

Start date
2017-03-23
Primary completion
2019-03-12
Completion
2019-04-03
First posted
2017-04-13
Last updated
2020-02-26

Locations

2 sites across 2 countries: France, Germany

Source: ClinicalTrials.gov record NCT03112629. Inclusion in this directory is not an endorsement.