Saint Luc Valve Registry (SaLVaRe)

March 18, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

The "Cliniques Universitaires Saint Luc" are one of the high specialized center in valvular heart diseases and valvular heart surgery. Aortic stenosis, mitral and aortic regurgitation are the three valve pathology that are mainly frequent and studied.

International guidelines in the management of valvular heart diseases are based on few limited old studies, mainly retrospective. And, a matter of concern is staying, about the timing of surgery for asymptomatic patients.

A prospective registry will help us to better understand the pathologies and try to better define guidelines criteria for surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

With this prospective registry, all patients with aortic stenosis, mitral and aortic regurgitation will be followed. The investigators will find followed patients not yet operated or until surgery, but also patient after surgery according to the presence or abscence of guidelines criteria.

It will permit to compare different kind of management of patients with valvular heart disease and to better define guidelines criteria for surgery.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint Luc - Université Catholique de Louvain
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with valvular heart disease who undergo an echocardiography at the Cliniques Universitaires Saint Luc.

Patients included must be > 18y and < 100 of age.

Description

Inclusion Criteria:

  • Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc".

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: every two years up to 10 years
From the date of the first echocardiography until the date of death from any cause, documented progression and surgery will be regularly assessed up to 10 years.
every two years up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Study Director: Vanoverschlde Jean-Louis, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (ESTIMATE)

November 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salvare

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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