Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Clinical Trial
— SaLVaReOfficial title:
Saint Luc Valve Registry
| NCT number | NCT02974218 |
| Other study ID # | Salvare |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2000 |
| Est. completion date | January 2025 |
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.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
Inclusion Criteria: - Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc". Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques Universitaires Saint Luc - Université Catholique de Louvain | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Barone-Rochette G, Piérard 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 — View Citation
Barone-Rochette G, Piérard 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 aorti — View Citation
Boodhwani 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/ — View Citation
Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10. — View Citation
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 Col — View Citation
de 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; — View Citation
de 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; discus — View Citation
de 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; — View Citation
de 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):1 — View Citation
le 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. J — View Citation
Maes F, Boulif J, Piérard 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. — View Citation
Montant P, Chenot F, Robert A, Vancraeynest D, Pasquet A, Gerber B, Noirhomme P, El Khoury G, Vanoverschelde JL. Long-term survival in asymptomatic patients with severe degenerative mitral regurgitation: a propensity score-based comparison between an earl — View Citation
Piérard 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. An — View Citation
Piérard 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 — View Citation
Pouleur AC, le Polain de Waroux JB, Goffinet C, Vancraeynest D, Pasquet A, Gerber BL, Vanoverschelde JL. Accuracy of the flow convergence method for quantification of aortic regurgitation in patients with central versus eccentric jets. Am J Cardiol. 2008 — View Citation
Rezzoug 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 — View Citation
Rezzoug N, Vaes B, Pasquet A, Gerber B, de Meester C, Van Pottelbergh G, Adriaensen W, Matheï C, DeGryse J, Vanoverschelde JL. Prevalence and Prognostic Impact of Valve Area-Gradient Patterns in Patients =80 Years With Moderate-to-Severe Aortic Stenosis ( — View Citation
Tribouilloy C, Rusinaru D, Charles V, Boulif J, Maes F, Lévy F, Pasquet A, Maréchaux 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):61 — View Citation
* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | every two years up to 10 years |