Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-04-21 @ 6:59 PM
Study NCT ID:
NCT02803957
Status:
RECRUITING
Last Update Posted:
2019-12-05
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 585}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.', 'timeFrame': 'Post-operative Day (POD) 30'}, {'measure': 'Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Degenerative', 'Mitral Regurgitation'], 'conditions': ['Mitral Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is a candidate for mitral valve repair with cardiopulmonary bypass\n* Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation\n* Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram\n* Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement\n* Anatomic and general suitability\n\nExclusion Criteria:\n\n* Prior mitral valve surgery\n* Concomitant cardiac procedures\n* Other cardiac procedures within 3 months'}, 'identificationModule': {'nctId': 'NCT02803957', 'acronym': 'ReChord', 'briefTitle': 'Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeoChord'}, 'officialTitle': 'Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair', 'orgStudyIdInfo': {'id': 'NeoChord: PR-610405-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000', 'interventionNames': ['Device: NeoChord DS1000']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair', 'interventionNames': ['Device: Surgical Mitral Valve Repair']}], 'interventions': [{'name': 'NeoChord DS1000', 'type': 'DEVICE', 'description': 'Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000', 'armGroupLabels': ['Treatment Group']}, {'name': 'Surgical Mitral Valve Repair', 'type': 'DEVICE', 'description': 'Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Junaid Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sutter Health/Alta Bates Summitt Medical Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frank Slachman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy General Hospital', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jack Boyd, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christian Shults, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30339', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Frederico Milla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Gerdisch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Franciscan Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stefano Shena, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Romano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David H Adams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai, Icahn School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isaac George, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '17110', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mubashir Mumtaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pinnacle Health', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Gleason, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Evelio Rodriguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St. Thomas', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor - Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22601', 'city': 'Winchester', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Basel Ramlawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Valley Health System | Virginia', 'geoPoint': {'lat': 39.18566, 'lon': -78.16333}}], 'centralContacts': [{'name': 'David H Adams, MD', 'role': 'CONTACT', 'email': 'david.adams@mountsinai.org', 'phone': '212-659-6820'}, {'name': 'Michael Borger, MD, Ph.D.', 'role': 'CONTACT', 'email': 'Michael.Borger@helios-kliniken.de', 'phone': '+49-341-865-1421'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeoChord', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}