Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04470102
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no data'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2020-07-08', 'studyFirstSubmitQcDate': '2020-07-12', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Outflow Tract (LVOT) gradient', 'timeFrame': '12 months in the medium-term follow-up', 'description': 'Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.'}], 'secondaryOutcomes': [{'measure': 'Systolic anterior motion of the mitral valve', 'timeFrame': '12 months in the medium-term follow-up', 'description': 'Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['edge-to-edge repair', 'mitral valve plastic (MVP)', 'Septal myectomy'], 'conditions': ['Hypertrophic Obstructive Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.', 'detailedDescription': 'A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent (either from the patient or a substitute decision-maker)\n* Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy\n\nExclusion Criteria:\n\n* indications for mitral valve replacement\n* Patient failure at any stage of the study'}, 'identificationModule': {'nctId': 'NCT04470102', 'acronym': 'PRIZMA-pilot', 'briefTitle': 'Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': '188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'isolated septal myectomy', 'description': 'Isolated extended septal myectomy', 'interventionNames': ['Procedure: Septal myectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Septal myectomy+ "edge-to-edge"', 'description': 'advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique', 'interventionNames': ['Procedure: mitral valve repair by edge-to-edge technique']}], 'interventions': [{'name': 'mitral valve repair by edge-to-edge technique', 'type': 'PROCEDURE', 'otherNames': ['Alfieri stitch'], 'description': 'transaortic access for mitral valve repair edge-to-edge', 'armGroupLabels': ['Septal myectomy+ "edge-to-edge"']}, {'name': 'Septal myectomy', 'type': 'PROCEDURE', 'otherNames': ['Septal myectomy (SM)'], 'description': 'isolated extended septal myectomy', 'armGroupLabels': ['isolated septal myectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander V. Bogachev-Prokophiev, MD, PhD', 'role': 'CONTACT', 'email': 'bogachev.prokophiev@gmail.com', 'phone': '+73833476029'}, {'name': 'Sergei Budagaev', 'role': 'CONTACT', 'email': 'ser.bud.med@gmail.com', 'phone': '89021606921'}], 'facility': '"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Alexander V. Bogachev-Prokophiev, MD, PhD', 'role': 'CONTACT', 'email': 'bogachev.prokophiev@gmail.com', 'phone': '+73833476029'}, {'name': 'Sergei A. Budagaev', 'role': 'CONTACT', 'email': 'ser.bud.med@gmail.com', 'phone': '+73833476029'}], 'overallOfficials': [{'name': 'Alexander V. Bogachev-Prokophiev, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'E.Meshalkin National medical research center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}