Study to Improve Outcomes in Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

791 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2019-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis

NCT01358513

Aortic Stenosis

COMPLETED

VALVOSOFT® Pivotal Study

NCT05235568

Aortic Valve Calcification Aortic Valve Stenosis

COMPLETED NA

Metabolic Determinants of the Progression of Aortic Stenosis

NCT01679431

Aortic Valve Stenosis

UNKNOWN

Intima-Medial Thickness Guidance of Primary Prevention in Relatives of Patients With Early onSet Atherosclerosis

NCT01330602

Atherosclerotic Cardiovascular Disease Cardiovascular Disease

UNKNOWN NA

Vascular Changes in Patients With Aotic Isthmus Stenosis After Interventional Therapy

NCT05903586

Aortic Isthmus Stenosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

symptomatic AS

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.

No interventions assigned to this group

asymptomatic AS

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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