Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-03 @ 4:44 AM
Study NCT ID:
NCT03674593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blind masking (Participant)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, prospective, semi-open, randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitral regurgitation degree measure', 'timeFrame': 'Two weeks', 'description': 'Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Surgical efficacy measure', 'timeFrame': 'One year', 'description': 'Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery'}, {'measure': 'ERO measure', 'timeFrame': 'Two weeks', 'description': 'Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitral Valve Chordae', 'Degenerative Mitral Valve Disease', 'Mitral Valve Chordae Replacement', 'Mitral Valve Chordae Translocation', 'Mitral Valve Chordae Prosthetics'], 'conditions': ['Degenerative Mitral Valve Disease']}, 'descriptionModule': {'briefSummary': 'The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve chordae.', 'detailedDescription': 'Summary: This study compares the efficacy and the safety of two surgical procedures for the treatment of mitral valve prolapse due to degeneration of the mitral valve: chordae replacement and the translocation of secondary mitral valve chordae.\n\nIn our study, researchers used the loop method proposed by von Oppel and Mohr in 2000. The main principle of the method of prosthetic chordae is the preservation of the native anatomy of the mitral valve. This principle is achieved by the implantation of artificial chordae made of ePTFE Gore-Tex threads.\n\nThe chordae replacement method essentially involves five stages:\n\n1. Measuring the required length of the chordae.\n2. Forming the loops.\n3. Fixation of the group of loops to the papillary muscles.\n4. Fixation of the chordal loops to the free edge of the valve.\n5. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse.\n\nChordae translocation is the alternative method, which does not require measurement and selection of chordae lengths. Chordae replacement is technically easier (less aortic clamping time) with comparable results.\n\nThe technique of translocation of secondary chordae essentially consists of three stages:\n\n1. Selection of the secondary chordae.\n2. Fixation of secondary chordae to the free edge of the valve.\n3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Isolated type II mitral valve insufficiency by A. Carpentier\n2. Mitral regurgitation degree \\>2\n3. Age \\>18 years\n4. Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Any other cardiac surgeries\n2. Age \\<18 years\n3. Multiple organ failure\n4. ReDo procedure\n5. Persistent atrial fibrillation\n6. Acute infective endocarditis\n7. Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT03674593', 'briefTitle': 'Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae', 'organization': {'class': 'OTHER', 'fullName': 'Tomsk National Research Medical Center of the Russian Academy of Sciences'}, 'officialTitle': 'Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae', 'orgStudyIdInfo': {'id': 'Mitral Valve Chordae'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitral valve chordae prosthesis', 'description': 'Patients of this group receive mitral valve chordae replacement performed in five stages:\n\n1. Measure the required length of the chordae.\n2. Forming loops.\n3. Fixation of the loop group to the papillary muscles.\n4. Fixation of chordal loops to the free edge of the valve.\n5. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse.', 'interventionNames': ['Procedure: Mitral valve chordae prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mitral valve chordae translocation', 'description': 'The technique of translocation of secondary chordae:\n\nThe method consists essentially of three stages:\n\n1. Selection of the secondary chordae.\n2. Fixation of secondary chordae to the free edge of the valve.\n3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.', 'interventionNames': ['Procedure: Mitral valve chordae translocation']}], 'interventions': [{'name': 'Mitral valve chordae prosthesis', 'type': 'PROCEDURE', 'otherNames': ['Chordae prosthesis'], 'description': 'The method consists of five stages:\n\n1. Measure the required length of the chords\n2. Forming loops\n3. Fixation of the loop group to the papillary muscles\n4. Fixation of chordal loops to the free edge of the valve\n5. Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse', 'armGroupLabels': ['Mitral valve chordae prosthesis']}, {'name': 'Mitral valve chordae translocation', 'type': 'PROCEDURE', 'otherNames': ['Chordae translocation'], 'description': 'The method consists essentially of three stages:\n\n1. Selection of the secondary chord.\n2. Fixation of secondary chords to the free edge of the valve.\n3. Annuloplasty support ring and hydraulic test to confirm the absence of prolapse.', 'armGroupLabels': ['Mitral valve chordae translocation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '634012', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Cardiology Research Institute, Tomsk NRMC', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}], 'overallOfficials': [{'name': 'Elena N. Pavlyukova, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tomsk NRMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomsk National Research Medical Center of the Russian Academy of Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}