Study to Improve Outcomes in Aortic Stenosis

Institut für Pharmakologie und Präventive Medizin

Status: Completed

Conditions: Aortic Valve Stenosis

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT03112629

Impulse enhanced

Details and patient eligibility

About

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.

Full 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.

Enrollment: 791 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

791 participants in 2 patient groups

symptomatic AS

Description:

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

Description:

Patients diagnosed with severe aortic stenosis in echocardiography who do not display symptoms