Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT04299334
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2020-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neochordae Technique in Mitral Valve Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008945', 'term': 'Mitral Valve Prolapse'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D016127', 'term': 'Heart Valve Prolapse'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-05', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-04', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'competency of mitral valve repair', 'timeFrame': '6 months follow up', 'description': 'by using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neochordae', 'Mitral valve repair'], 'conditions': ['Mitral Valve Prolapse', 'Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.\n\nIn our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.', 'detailedDescription': 'Mitral regurgitation (prolapse) and mitral stenosis are examples of diseases that affect the mitral valve. In mitral regurgitation, the leaflets do not close tightly and sway up and down allowing the blood to flow backward from the left ventricle into the left atrium. on the other hand, the mitral stenosis is caused by folding of thick leaflets of the valve which fuses together leading to low blood flow from the left atrium into the left ventricle and these cases are excluded from our trial. In mitral regurgitation, Surgeons prefer the mitral valve repair over the mitral valve replacement, But still, there are a lot of challenges towards this technique.\n\nFor decades, Surgeons used a lot of techniques to determine the length of neochordae includes that:\n\nDetermination of neochordal length by transoesophageal echocardiography or by using a landmark as a direct measurement. Previously, the surgeon applying the fixed loop length technique by using a custom-made caliper, and on the distance between the edge of a non-prolapsing segment and the tip of the papillary muscle (usually P1) to define the correct loop length. There are different types of papillary muscle and chordae as regards the shape, morphology, and length. So this reference distance is not fixed.\n\nAdjusting neochordal length according to valve function. Length is chosen when the regurgitation is completely removed. Existing of a large number of neochordae will make this process more complex for the surgeon to decide.\n\nMitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.\n\nIn our novel technique, Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prolapsed or ruptured chordae\n* Either degenerative or ischemic\n\nExclusion Criteria:\n\n* Patient with redo Mitral Valve surgery\n* Patient with severe rheumatic mitral stenosis (MS).'}, 'identificationModule': {'nctId': 'NCT04299334', 'briefTitle': 'Neochordae Technique in Mitral Valve Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Heart Institute, Egypt'}, 'officialTitle': 'A Novel Adjustable Neochordae Technique in Mitral Valve Repair', 'orgStudyIdInfo': {'id': 'NHI-MR-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'adjustable neochordae Technique', 'type': 'PROCEDURE', 'description': 'Classic ring annuloplasty will be done using Carpentier or physio ring, then neochordal placement will be done using the looping technique. The length of the chordae is adjusted to achieve the optimal length.\n\nIn this study, Surgeons use relatively short loops because of the augmentation of the length with extra loops suspended with Gortex. Placement of at least 8-12 chordae of the corresponding heads of the papillary muscle tip to achieve proper management of the prolapse and longevity of the repair.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12511', 'city': 'El-Sheikh Zayed City', 'state': 'Giza Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Yosry thakeb, M.D.', 'role': 'CONTACT', 'email': 'yosrythakeb@gmail.com', 'phone': '+2 01156760602'}], 'facility': 'Yosry Mahmoud Thakeb', 'geoPoint': {'lat': 30.04861, 'lon': 30.99056}}], 'centralContacts': [{'name': 'Samar Sakr, BSc', 'role': 'CONTACT', 'email': 'samarsakr@students.mans.edu.eg', 'phone': '+2 01020430546'}, {'name': 'Mahmoud Morsi, MBBCh', 'role': 'CONTACT', 'email': 'mah.atef93@gmail.com', 'phone': '+2 01090032210'}], 'overallOfficials': [{'name': 'Yosry Thakeb, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiothoracic Surgery Department, National Heart Institute, Giza, Egypt.'}, {'name': 'Amr Zaher, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adjunct Professor, Biomedical sciences program, Zewail City of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart Institute, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yosry Mahmoud Thakeb', 'investigatorAffiliation': 'National Heart Institute, Egypt'}}}}