Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-02 @ 8:37 AM
Study NCT ID:
NCT02974218
Status:
UNKNOWN
Last Update Posted:
2019-03-19
First Post:
2016-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saint Luc Valve Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2016-11-22', 'lastUpdatePostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'every two years up to 10 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)']}, 'referencesModule': {'references': [{'pmid': '27634121', 'type': 'RESULT', '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 Coll Cardiol. 2016 Sep 20;68(12):1297-307. doi: 10.1016/j.jacc.2016.06.047.'}, {'pmid': '26754575', 'type': 'RESULT', '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 12;16:7. doi: 10.1186/s12872-016-0184-8.'}, {'pmid': '26298872', 'type': 'RESULT', '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;150(5):1100-8. doi: 10.1016/j.jtcvs.2015.07.053. Epub 2015 Jul 28.'}, {'pmid': '26219495', 'type': 'RESULT', 'citation': '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': '26089012', 'type': 'RESULT', 'citation': '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': '25721823', 'type': 'RESULT', '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; discussion 437-8. doi: 10.1093/ejcts/ezv050. Epub 2015 Feb 26.'}, {'pmid': '25011718', 'type': 'RESULT', 'citation': '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': '24777938', 'type': 'RESULT', 'citation': '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': '24656668', 'type': 'RESULT', '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):1913-20. doi: 10.1016/j.jtcvs.2014.02.010. Epub 2014 Feb 10.'}, {'pmid': '24200400', 'type': 'RESULT', 'citation': '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': '24100045', 'type': 'RESULT', 'citation': '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': '21955470', 'type': 'RESULT', '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;142(6):1430-8. doi: 10.1016/j.jtcvs.2011.08.021. Epub 2011 Sep 28.'}, {'pmid': '21310391', 'type': 'RESULT', 'citation': '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': '21292284', 'type': 'RESULT', '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/j.jtcvs.2010.12.006. Epub 2011 Feb 3.'}, {'pmid': '19679280', 'type': 'RESULT', '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. JACC Cardiovasc Imaging. 2009 Aug;2(8):931-9. doi: 10.1016/j.jcmg.2009.04.013.'}, {'pmid': '19660385', 'type': 'RESULT', '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 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': '19632855', 'type': 'RESULT', '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: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.'}, {'pmid': '18678309', 'type': 'RESULT', '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 Aug 15;102(4):475-80. doi: 10.1016/j.amjcard.2008.04.011. Epub 2008 May 24.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nInternational 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.\n\nA prospective registry will help us to better understand the pathologies and try to better define guidelines criteria for surgery.', 'detailedDescription': '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.\n\nIt will permit to compare different kind of management of patients with valvular heart disease and to better define guidelines criteria for surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with valvular heart disease who undergo an echocardiography at the Cliniques Universitaires Saint Luc.\n\nPatients included must be \\> 18y and \\< 100 of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc".\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02974218', 'acronym': 'SaLVaRe', 'briefTitle': 'Saint Luc Valve Registry', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Saint Luc Valve Registry', 'orgStudyIdInfo': {'id': 'Salvare'}}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'de Meester Christophe, PhD', 'role': 'CONTACT', 'email': 'christophe.demeester@uclouvain.be', 'phone': '003227642816', 'phoneExt': '42816'}], 'facility': 'Cliniques Universitaires Saint Luc - Université Catholique de Louvain', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'de Meester Christophe, PhD', 'role': 'CONTACT', 'email': 'christophe.demeester@uclouvain.be', 'phone': '003227642816', 'phoneExt': '42816'}], 'overallOfficials': [{'name': 'Vanoverschlde Jean-Louis, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}