Study to Improve Outcomes in Aortic Stenosis

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03112629
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-21
• Study Start: 2017-03-23
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Primary Completion: 2019-03-12
• Study Completion: 2019-04-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 791

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Referral rates of intervention or conservative treatment in symptomatic severe AS (SAVR vs. TAVI vs. medical treatment) in different types of hospitals	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

Name	Time	Method
Outcomes (survival) (intervention vs. conservative treatment)	12 months	rates of death
Transition of asymptomatic in symptomatic severe aortic stenosis (clinical evaluation of shortness of breath, chest pain and/or dizziness or syncope)	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)

Trial Locations

Locations (2)

Bichat Hospital Paris; 🇫🇷 Paris, France

Department of Cardiology and Angiology, University of Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany