Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00629902
Status:
COMPLETED
Last Update Posted:
2008-05-12
First Post:
2008-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heart Valve Prosthesis-Patient Mismatch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-09', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart valve prosthesis'], 'conditions': ['Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '17723820', 'type': 'BACKGROUND', 'citation': 'Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. doi: 10.1016/j.jtcvs.2007.04.031.'}, {'pmid': '15808760', 'type': 'BACKGROUND', 'citation': 'Li M, Dumesnil JG, Mathieu P, Pibarot P. Impact of valve prosthesis-patient mismatch on pulmonary arterial pressure after mitral valve replacement. J Am Coll Cardiol. 2005 Apr 5;45(7):1034-40. doi: 10.1016/j.jacc.2004.10.073.'}, {'pmid': '17339554', 'type': 'BACKGROUND', 'citation': 'Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.', 'detailedDescription': 'Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Tertiary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years with a clinical condition of mitral valve prosthesis\n\nExclusion Criteria:\n\n* Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)\n* Concomitant aortic valve prosthesis and tricuspid valve prosthesis\n* Presence of \\> +2 aortic valve regurgitation and/or mild aortic stenosis\n* Prosthetic mitral valve replacement operation \\< 6 months\n* Left ventricular ejection fraction \\< 50%\n* Chronic obstructive pulmonary disease\n* Concomitant hypertrophic cardiomyopathy, atrial septal defect\n* Patients with poor ehocardiographic window'}, 'identificationModule': {'nctId': 'NCT00629902', 'briefTitle': 'Heart Valve Prosthesis-Patient Mismatch', 'organization': {'class': 'OTHER', 'fullName': 'Florence Nightingale Hospital, Istanbul'}, 'officialTitle': 'Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement', 'orgStudyIdInfo': {'id': 'AT-1974'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A1', 'description': 'Patients with prosthesis-patient mismatch after mitral valve replacement'}, {'label': 'A2', 'description': 'Patients without prosthesis mismatch after mitral valve replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34381', 'city': 'Istanbul', 'state': 'Sisli', 'country': 'Turkey (Türkiye)', 'facility': 'T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Saide Aytekin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florence Nightingale Hospital, Istanbul', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Saide Aytekin', 'oldOrganization': 'Florence Nightingale Hospital'}}}}