Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT03581656
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ChordArt System for Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, multi-center, prospective, non-randomized study. The study is conducted in accordance with the guidelines of the Mitral Valve Academic Research Consortium (MVARC) regarding study design and endpoint definition as well as International Standards Organization 5840-3.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-09', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'At 30 days from implant procedure', 'description': 'The frequency of all-cause mortality'}, {'measure': 'Major adverse events', 'timeFrame': 'At 30 days from implant procedure', 'description': 'The frequency of pre-determined major adverse events'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'End of Implantation Procedure', 'description': 'The technical success will be measured by the absence of procedural mortality, successful access, delivery of the ChordArt implant \\& retrieval of the ChordArt delivery system as well as successful ChordArt deployment, positioning and freedom from emergency surgery or re-intervention related to the device or access procedure.'}, {'measure': 'Device Performance', 'timeFrame': 'At 30 days', 'description': 'The device performance will be measured by the reduction of Mitral Regurgitation by Echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Degenerative Mitral Leaflet Prolapse', 'Heart Disease', 'Minimally Invasive'], 'conditions': ['Mitral Valve Repair', 'Mitral Regurgitation', 'Mitral Valve Insufficiency']}, 'referencesModule': {'references': [{'pmid': '11568020', 'type': 'BACKGROUND', 'citation': 'Mohty D, Orszulak TA, Schaff HV, Avierinos JF, Tajik JA, Enriquez-Sarano M. Very long-term survival and durability of mitral valve repair for mitral valve prolapse. Circulation. 2001 Sep 18;104(12 Suppl 1):I1-I7. doi: 10.1161/hc37t1.094903.'}, {'pmid': '16208620', 'type': 'BACKGROUND', 'citation': 'Urbanski PP. Modified technique of chordal replacement for mitral valve repair. Thorac Cardiovasc Surg. 2005 Oct;53(5):315-7. doi: 10.1055/s-2005-865685.'}], 'seeAlsoLinks': [{'url': 'http://www.coremedic.ch/about-us/', 'label': "Sponsor's Website"}, {'url': 'https://www.meditrialeurope.com/', 'label': "Collaborator's Website"}]}, 'descriptionModule': {'briefSummary': 'The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.', 'detailedDescription': 'ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail\n* Left Ventricular Ejection Fraction \\>20%\n* New York Heart Association functional class II to IV\n* Able and willing to give informed consent and follow protocol procedures.\n\nExclusion Criteria:\n\n* Life expectancy \\<1 year\n* Hemodynamic instability\n* Severe untreated ischemic disease\n* Pulmonary Hypertension\n* Any prior mitral valve surgery or transcatheter mitral valve procedure\n* Stroke or transient ischemic event within 30 days before randomization\n* Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.\n* Renal insufficiency\n* Acute anemia\n* Chronic obstructive pulmonary disease\n* Severe right ventricular dysfunction\n* Hepatic insufficiency\n* Patient is participating in other investigational studies'}, 'identificationModule': {'nctId': 'NCT03581656', 'acronym': 'CHAGALL', 'briefTitle': 'ChordArt System for Mitral Regurgitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoreMedic GmbH'}, 'officialTitle': 'ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail', 'orgStudyIdInfo': {'id': 'PR-000274-001'}, 'secondaryIdInfos': [{'id': 'CHAGALL', 'type': 'OTHER', 'domain': 'Other Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm', 'description': 'The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax.', 'interventionNames': ['Device: ChordArt System']}], 'interventions': [{'name': 'ChordArt System', 'type': 'DEVICE', 'description': 'The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.', 'armGroupLabels': ['Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08410', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santariskiu Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Kestutis Rucinskas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Surgery Centre, Santariskiu Vilnius'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoreMedic GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}