Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)SaLVaReNCT02974218
Saint Luc Valve Registry
An observational study of Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)
- How many people
- 5,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2000to Jan 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc".
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc - Université Catholique de Louvain
Brussels, 1200
de Meester Christophe, PhD, 003227642816 ext. 42816, christophe.demeester@uclouvain.be
About this study
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.
Read the 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.
- Medical subject headings
- Gastroesophageal Reflux, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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.
Measured: every two years up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startJan 2000
- Primary completionJan 2020 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanoverschlde Jean-Louis, MD, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974218
- Sponsor's protocol ID
- Salvare
- Acronym
- SaLVaRe
- Status last verified
- Mar 2019
- First submitted
- 18 Nov 2016
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clavel MA, Tribouilloy C, Vanoverschelde JL, Pizarro R, Suri RM, Szymanski C, Lazam S, Oberti P, Michelena HI, Jaffe A, Enriquez-Sarano M. Association of B-Type Natriuretic Peptide With Survival in Patients With Degenerative Mitral Regurgitation. J Am Coll Cardiol. 2016 Sep 20;68(12):1297-307. doi: 10.1016/j.jacc.2016.06.047.
PubMed 27634121Rezzoug N, Vaes B, de Meester C, Degryse J, Van Pottelbergh G, Mathei C, Adriaensen W, Pasquet A, Vanoverschelde JL. The clinical impact of valvular heart disease in a population-based cohort of subjects aged 80 and older. BMC Cardiovasc Disord. 2016 Jan 12;16:7. doi: 10.1186/s12872-016-0184-8.
PubMed 26754575de Meester C, Gerber BL, Vancraeynest D, Pouleur AC, Noirhomme P, Pasquet A, El Khoury G, Vanoverschelde JL. Early surgical intervention versus watchful waiting and outcomes for asymptomatic severe aortic regurgitation. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1100-8. doi: 10.1016/j.jtcvs.2015.07.053. Epub 2015 Jul 28.
PubMed 26298872Rezzoug N, Vaes B, Pasquet A, Gerber B, de Meester C, Van Pottelbergh G, Adriaensen W, Mathei C, DeGryse J, Vanoverschelde JL. Prevalence and Prognostic Impact of Valve Area-Gradient Patterns in Patients >/=80 Years With Moderate-to-Severe Aortic Stenosis (from the Prospective BELFRAIL Study). Am J Cardiol. 2015 Sep 15;116(6):925-32. doi: 10.1016/j.amjcard.2015.05.062. Epub 2015 Jun 26.
PubMed 26219495Tribouilloy C, Rusinaru D, Charles V, Boulif J, Maes F, Levy F, Pasquet A, Marechaux S, Vanoverschelde JL. Progression of Low-Gradient, Low-Flow, Severe Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Am J Cardiol. 2015 Aug 15;116(4):612-7. doi: 10.1016/j.amjcard.2015.05.023. Epub 2015 May 21.
PubMed 26089012de Kerchove L, Mastrobuoni S, Boodhwani M, Astarci P, Rubay J, Poncelet A, Vanoverschelde JL, Noirhomme P, El Khoury G. The role of annular dimension and annuloplasty in tricuspid aortic valve repair. Eur J Cardiothorac Surg. 2016 Feb;49(2):428-37; discussion 437-8. doi: 10.1093/ejcts/ezv050. Epub 2015 Feb 26.
PubMed 25721823Barone-Rochette G, Pierard S, De Meester de Ravenstein C, Seldrum S, Melchior J, Maes F, Pouleur AC, Vancraeynest D, Pasquet A, Vanoverschelde JL, Gerber BL. Prognostic significance of LGE by CMR in aortic stenosis patients undergoing valve replacement. J Am Coll Cardiol. 2014 Jul 15;64(2):144-54. doi: 10.1016/j.jacc.2014.02.612.
PubMed 25011718Maes F, Boulif J, Pierard S, de Meester C, Melchior J, Gerber B, Vancraeynest D, Pouleur AC, Lazam S, Pasquet A, Vanoverschelde JL. Natural history of paradoxical low-gradient severe aortic stenosis. Circ Cardiovasc Imaging. 2014 Jul;7(4):714-22. doi: 10.1161/CIRCIMAGING.113.001695. Epub 2014 Apr 28.
PubMed 24777938de Meester C, Pasquet A, Gerber BL, Vancraeynest D, Noirhomme P, El Khoury G, Vanoverschelde JL. Valve repair improves the outcome of surgery for chronic severe aortic regurgitation: a propensity score analysis. J Thorac Cardiovasc Surg. 2014 Nov;148(5):1913-20. doi: 10.1016/j.jtcvs.2014.02.010. Epub 2014 Feb 10.
PubMed 24656668Pierard S, de Meester C, Seldrum S, Pasquet A, Gerber B, Vancraeynest D, Robert A, El Khoury G, Noirhomme P, Vanoverschelde JL. Impact of preoperative symptoms on postoperative survival in severe aortic stenosis: implications for the timing of surgery. Ann Thorac Surg. 2014 Mar;97(3):803-9. doi: 10.1016/j.athoracsur.2013.08.059. Epub 2013 Nov 5.
PubMed 24200400Barone-Rochette G, Pierard S, Seldrum S, de Meester de Ravenstein C, Melchior J, Maes F, Pouleur AC, Vancraeynest D, Pasquet A, Vanoverschelde JL, Gerber BL. Aortic valve area, stroke volume, left ventricular hypertrophy, remodeling, and fibrosis in aortic stenosis assessed by cardiac magnetic resonance imaging: comparison between high and low gradient and normal and low flow aortic stenosis. Circ Cardiovasc Imaging. 2013 Nov;6(6):1009-17. doi: 10.1161/CIRCIMAGING.113.000515. Epub 2013 Oct 7.
PubMed 24100045de Kerchove L, Boodhwani M, Glineur D, Vandyck M, Vanoverschelde JL, Noirhomme P, El Khoury G. Valve sparing-root replacement with the reimplantation technique to increase the durability of bicuspid aortic valve repair. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1430-8. doi: 10.1016/j.jtcvs.2011.08.021. Epub 2011 Sep 28.
PubMed 21955470Pierard S, Seldrum S, de Meester C, Pasquet A, Gerber B, Vancraeynest D, El Khoury G, Noirhomme P, Robert A, Vanoverschelde JL. Incidence, determinants, and prognostic impact of operative refusal or denial in octogenarians with severe aortic stenosis. Ann Thorac Surg. 2011 Apr;91(4):1107-12. doi: 10.1016/j.athoracsur.2010.12.052. Epub 2011 Feb 18.
PubMed 21310391Boodhwani M, de Kerchove L, Watremez C, Glineur D, Vanoverschelde JL, Noirhomme P, El Khoury G. Assessment and repair of aortic valve cusp prolapse: implications for valve-sparing procedures. J Thorac Cardiovasc Surg. 2011 Apr;141(4):917-25. doi: 10.1016/j.jtcvs.2010.12.006. Epub 2011 Feb 3.
PubMed 21292284le Polain de Waroux JB, Pouleur AC, Robert A, Pasquet A, Gerber BL, Noirhomme P, El Khoury G, Vanoverschelde JL. Mechanisms of recurrent aortic regurgitation after aortic valve repair: predictive value of intraoperative transesophageal echocardiography. JACC Cardiovasc Imaging. 2009 Aug;2(8):931-9. doi: 10.1016/j.jcmg.2009.04.013.
PubMed 19679280