Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT03195595
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2017-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating of postoperative pain by using numerical rating scales (NRS)', 'timeFrame': 'one year', 'description': 'its a score result from gathered information from the patient'}], 'secondaryOutcomes': [{'measure': 'Evaluating early postoperative outcome', 'timeFrame': 'one year', 'description': 'e.g., bleeding'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration aiming to compare minimal invasive technique to conventional median sternotomy for mitral valve surgery regarding early postoperative outcomes and pain', 'detailedDescription': 'This is retrospective study that will be done in Cardiothoracic surgery department in Assuit university hospitals for one year duration and the study tools will be:\n\nPart I (Demographic data):\n\n* Age, Gender, Weight, Height ,Smoke history\n\nPart II (Preoperative data):\n\n* Medical history, Clinical assessment, Preoperative investigation\n\nPart III (Intraoperative data):\n\n* Surgical time, and Ischemic time\n\nPart IV (Postoperative data):\n\n* Early ambulation, ICU stay, length of ventilation, using of analgesic drugs, post op bleeding, deaths'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'It includes groups of population above age of 18 with symptomatic mitral valve disease indicated for valve surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients with mitral valve disease indicated for valve surgery\n\nExclusion Criteria:\n\n* Double valve disease or other valve disease\n* Mitral or aortic valve disease associated with ischemic heart disease\n* Mitral or aortic valve disease associated with congenital heart disease\n* Patients subjected to prior heart surgery'}, 'identificationModule': {'nctId': 'NCT03195595', 'briefTitle': 'Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Minimal Invasive Mitral Valve Replacement Versus Conventional Median Sternotomy Approach', 'orgStudyIdInfo': {'id': '17100176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mitral valve replacement', 'description': 'patients whom underwent Mitral valve replacement through minimal invasive incision', 'interventionNames': ['Device: mitral valve replacement', 'Device: conventional mitral valve replacement']}, {'label': 'conventional mitral valve replacement', 'description': 'patients whom underwent Mitral valve replacement through conventional sternotomy'}], 'interventions': [{'name': 'mitral valve replacement', 'type': 'DEVICE', 'description': 'early postoperative outcome regarding pain in minimal invasive technique', 'armGroupLabels': ['mitral valve replacement']}, {'name': 'conventional mitral valve replacement', 'type': 'DEVICE', 'description': 'early postoperative outcome regarding pain in conventional median sternotomy', 'armGroupLabels': ['mitral valve replacement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Elhussein abdelmottaleb, master', 'role': 'CONTACT', 'email': 'husseinmoh24@gmail.com', 'phone': '00201003873076'}], 'facility': 'Assiut University Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Elhussein abdelmottaleb, master', 'role': 'CONTACT', 'email': 'husseinmoh24@gmail.com', 'phone': '00201003873076'}], 'overallOfficials': [{'name': 'mohamed A nady, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuit university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at cardiothoracic surgery', 'investigatorFullName': 'Elhussein Mohamed Abdelmottaleb', 'investigatorAffiliation': 'Assiut University'}}}}