NCT02974218

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
16.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

20 years

First QC Date

November 18, 2016

Last Update Submit

March 18, 2019

Conditions

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc - Université Catholique de Louvain

Brussels, 1200, Belgium

RECRUITING

Related Publications (18)

  • 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.

    PMID: 27634121RESULT

  • 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 12;16:7. doi: 10.1186/s12872-016-0184-8.

    PMID: 26754575RESULT

  • 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;150(5):1100-8. doi: 10.1016/j.jtcvs.2015.07.053. Epub 2015 Jul 28.

    PMID: 26298872RESULT

  • Rezzoug 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.

    PMID: 26219495RESULT

  • Tribouilloy 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.

    PMID: 26089012RESULT

  • 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; discussion 437-8. doi: 10.1093/ejcts/ezv050. Epub 2015 Feb 26.

    PMID: 25721823RESULT

  • Barone-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.

    PMID: 25011718RESULT

  • Maes 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.

    PMID: 24777938RESULT

  • 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):1913-20. doi: 10.1016/j.jtcvs.2014.02.010. Epub 2014 Feb 10.

    PMID: 24656668RESULT

  • Pierard 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.

    PMID: 24200400RESULT

  • Barone-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.

    PMID: 24100045RESULT

  • 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;142(6):1430-8. doi: 10.1016/j.jtcvs.2011.08.021. Epub 2011 Sep 28.

    PMID: 21955470RESULT

  • Pierard 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.

    PMID: 21310391RESULT

  • 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/j.jtcvs.2010.12.006. Epub 2011 Feb 3.

    PMID: 21292284RESULT

  • 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. JACC Cardiovasc Imaging. 2009 Aug;2(8):931-9. doi: 10.1016/j.jcmg.2009.04.013.

    PMID: 19679280RESULT

  • 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 early surgical strategy and a conservative treatment approach. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1339-48. doi: 10.1016/j.jtcvs.2009.03.046. Epub 2009 Jun 26.

    PMID: 19660385RESULT

  • 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: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.

    PMID: 19632855RESULT

  • 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 Aug 15;102(4):475-80. doi: 10.1016/j.amjcard.2008.04.011. Epub 2008 May 24.

    PMID: 18678309RESULT

MeSH Terms

Conditions

Gastroesophageal RefluxDisease

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vanoverschlde Jean-Louis, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY DIRECTOR

Central Study Contacts

de Meester Christophe, PhD

CONTACT

003227642816christophe.demeester@uclouvain.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 28, 2016

Study Start

January 1, 2000

Primary Completion

January 1, 2020

Study Completion

January 1, 2025

Last Updated

March 19, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)