Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-10 @ 4:57 AM
Study NCT ID:
NCT03038204
Status:
UNKNOWN
Last Update Posted:
2017-01-31
First Post:
2017-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-28', 'studyFirstSubmitDate': '2017-01-16', 'studyFirstSubmitQcDate': '2017-01-28', 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age (years)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients'}, {'measure': 'Body mass index (kg/m^2)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients.'}, {'measure': 'Body surface area (m^2)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients.'}, {'measure': 'NYHA (I, II, III or IV)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients.'}, {'measure': 'EuroSCORE', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients.'}, {'measure': 'Six minute walk test (m)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients.'}, {'measure': 'Hypertension (absence, stage 1, 2 or 3)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients. Impact of the factor on the long-term survival.'}, {'measure': 'Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients. Impact of the factor on the long-term survival.'}, {'measure': 'Obesity (absence, class 1, 2 or 3)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients. Impact of the factor on the long-term survival.'}, {'measure': 'Multifocal atherosclerosis (presence or absence)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients. Impact of the factor on the long-term survival.'}, {'measure': 'COPD (absence, GOLD 1, 2, 3 or 4)', 'timeFrame': '1 year', 'description': 'Description and comparison of groups of patients. Impact of the factor on the long-term survival.'}], 'primaryOutcomes': [{'measure': 'Mitral regurgitation severity (1,2 or 3)', 'timeFrame': '1 year', 'description': 'Mitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.'}], 'secondaryOutcomes': [{'measure': 'End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)', 'timeFrame': '1 year', 'description': 'Assessment of left ventricular dimensions.'}, {'measure': 'Ejection fraction (%)', 'timeFrame': '1 year', 'description': 'Assessment of myocardial contractility.'}, {'measure': 'Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)', 'timeFrame': '1 year', 'description': 'Assessment of the impact of the surgery on the mitral valve configuration.'}, {'measure': 'Tenting area (mm^2)', 'timeFrame': '1 year', 'description': 'Assessment of the impact of the surgery on the configuration of the mitral valve.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Papillary muscles approximation'], 'conditions': ['Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '22549757', 'type': 'BACKGROUND', 'citation': 'Manabe S, Shimokawa T, Fukui T, Tabata M, Takanashi S. Impact of papillary muscle approximation on mitral valve configuration in the surgical correction of ischemic mitral regurgitation. Thorac Cardiovasc Surg. 2012 Jun;60(4):269-74. doi: 10.1055/s-0032-1304536. Epub 2012 May 1.'}, {'pmid': '23882872', 'type': 'RESULT', 'citation': 'Roshanali F, Vedadian A, Shoar S, Naderan M, Mandegar MH. Efficacy of papillary muscle approximation in preventing functional mitral regurgitation recurrence in high-risk patients with ischaemic cardiomyopathy and mitral regurgitation. Acta Cardiol. 2013 Jun;68(3):271-8. doi: 10.1080/ac.68.3.2983421.'}, {'pmid': '25500293', 'type': 'RESULT', 'citation': "Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6."}, {'pmid': '18036963', 'type': 'RESULT', 'citation': 'Rama A, Praschker L, Barreda E, Gandjbakhch I. Papillary muscle approximation for functional ischemic mitral regurgitation. Ann Thorac Surg. 2007 Dec;84(6):2130-1. doi: 10.1016/j.athoracsur.2007.04.056.'}, {'pmid': '18544392', 'type': 'RESULT', 'citation': 'Ishikawa S, Ueda K, Kawasaki A, Neya K, Suzuki H. Papillary muscle sandwich plasty for ischemic mitral regurgitation: a new simple technique. J Thorac Cardiovasc Surg. 2008 Jun;135(6):1384-6. doi: 10.1016/j.jtcvs.2007.12.034. No abstract available.'}, {'pmid': '23428660', 'type': 'RESULT', 'citation': 'Yamaguchi A, Adachi K, Yuri K, Kimura N, Kimura C, Tamura A, Adachi H. Reduction of mitral valve leaflet tethering by procedures targeting the subvalvular apparatus in addition to mitral annuloplasty. Circ J. 2013;77(6):1461-5. doi: 10.1253/circj.cj-12-1148. Epub 2013 Feb 20.'}, {'pmid': '24893928', 'type': 'RESULT', 'citation': 'Wakasa S, Kubota S, Shingu Y, Ooka T, Tachibana T, Matsui Y. The extent of papillary muscle approximation affects mortality and durability of mitral valve repair for ischemic mitral regurgitation. J Cardiothorac Surg. 2014 Jun 3;9:98. doi: 10.1186/1749-8090-9-98.'}]}, 'descriptionModule': {'briefSummary': 'Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt.', 'detailedDescription': 'Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction. Among several surgical procedures, mitral ring annuloplasty has been the method of choice for a considerable period. However, mitral regurgitation recurrence after surgery has a reported occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory outcomes. The pathophysiology of IMR is complex and results from the imbalance between closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular chamber, and displacement of papillary muscles in apical and lateral direction increase the tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial contractility decrease closing forces, which lead to impaired leaflet coaptation and appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an integrated approach affecting all units of the pathogenesis of MR recurrence.\n\nRecent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt. This study is conducted to identify the positive qualities and safety of this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic cardiomyopathy and coexisting IMR were enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic cardiomyopathy,\n* Ischemic mitral regurgitation.\n\nExclusion Criteria:\n\n* Degenerative mitral valve disease,\n* Unstable angina,\n* Recent myocardial infarction (\\< 6 months),\n* Papillary muscles rupture,\n* Severe right ventricular dysfunction,\n* Multiple organ failures,\n* Concomitant left ventricular reconstruction,\n* Aortic valve procedures.'}, 'identificationModule': {'nctId': 'NCT03038204', 'acronym': 'PMA', 'briefTitle': 'The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'The Federal Centre of Cardiovascular Surgery, Russia'}, 'officialTitle': 'The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation', 'orgStudyIdInfo': {'id': 'FederalCCS 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PMA+MVA+CABG', 'description': 'patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation.', 'interventionNames': ['Procedure: The papillary muscle approximation']}, {'label': 'MVA+CABG', 'description': 'patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty.'}], 'interventions': [{'name': 'The papillary muscle approximation', 'type': 'PROCEDURE', 'description': 'Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution.\n\nAfter coronary anastomosis, the mitral valve is exposed by a transseptal incision.\n\nThe papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose.\n\nAnnuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured.', 'armGroupLabels': ['PMA+MVA+CABG']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Federal Centre of Cardiovascular Surgery, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Cardiovascular surgeon', 'investigatorFullName': 'Mikulyak Artur', 'investigatorAffiliation': 'The Federal Centre of Cardiovascular Surgery, Russia'}}}}