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Saint Luc Valve Registry (SaLVaRe)

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ClinicalTrials.gov Identifier: NCT02974218
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary:

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 timiong 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.


Condition or disease
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)

Detailed Description:

With this prospective registry, all patients with aortic stenosis, mitral and aortic regurgitation will be followed. We 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 [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Saint Luc Valve Registry
Study Start Date : January 2000
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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, doumented progression and surgery will be regularly assessed up to 10 years.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974218


Contacts
Contact: de Meester Christophe, PhD 003227642816 ext 42816 christophe.demeester@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint Luc - Université Catholique de Louvain Recruiting
Brussels, Belgium, 1200
Contact: de Meester Christophe, PhD    003227642816 ext 42816    christophe.demeester@uclouvain.be   
Sponsors and Collaborators
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 of Results:

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02974218     History of Changes
Other Study ID Numbers: Salvare
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases