Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-08 @ 9:31 PM
Study NCT ID:
NCT00512005
Status:
UNKNOWN
Last Update Posted:
2009-06-24
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-06-23', 'studyFirstSubmitDate': '2007-08-06', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2009-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System', 'timeFrame': 'Intra-procedure and peri-procedure'}], 'secondaryOutcomes': [{'measure': 'Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes', 'timeFrame': '1, 3, 6, 12, 18, 24 months and annually thereafter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Functional Mitral Regurgitation (FMR)', 'Ischemic Mitral Regurgitation', 'Less invasive repair', 'Percutaneous MV repair', 'Mitral Valve Repair', 'Heart Failure', 'Left Ventricular Dysfunction'], 'conditions': ['Mitral Valve Regurgitation', 'Left Ventricular Dysfunction', 'Heart Failure', 'Mitral Insufficiency', 'Mitral Incompetence', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.', 'detailedDescription': 'Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.\n\nThe iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.\n* NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%\n\nKey Exclusion Criteria:\n\n* History of pericarditis.\n* Creatinine \\> 2.2 at the time of the procedure\n* INR \\> 1.8 at the time of the procedure\n* Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).\n* Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).\n* Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure\n* Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).\n* Structural abnormality of the mitral valve\n* Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.\n* Pericardial effusion \\>5 mm via echocardiography.\n* Posterior wall end-diastolic dimension \\>1.3 cm.\n* Left ventricular end diastolic diameter \\> 7.0 cm.'}, 'identificationModule': {'nctId': 'NCT00512005', 'acronym': 'VIVID', 'briefTitle': 'VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myocor'}, 'officialTitle': 'Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study', 'orgStudyIdInfo': {'id': '030301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Percutaneous mitral valve repair', 'type': 'DEVICE', 'otherNames': ['iCoapsys System'], 'description': 'Ventricular reshaping to treat functional mitral insufficiency'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pamela Hyde, RN', 'role': 'CONTACT', 'email': 'Pamela.hyde@emoryhealthcare.org', 'phone': '404-712-7665'}, {'name': 'Peter Block, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claudia Focks', 'role': 'CONTACT', 'email': 'cfocks@enh.org', 'phone': '847-570-2366'}, {'name': 'Theodore Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Evanston Northwestern Healthcare - Evanston Hospital', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '66204', 'city': 'Shawnee Mission', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Millie Salkind', 'role': 'CONTACT', 'email': 'msalkind@kcheart.com', 'phone': '913-671-6516'}, {'name': 'Paul Kramer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shawnee Mission Hospital', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '55440', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Olson, RN', 'role': 'CONTACT', 'email': 'sara.olson@allina.com', 'phone': '612-863-7601'}, {'name': 'Wesley Pedersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Cyril J. Schweich, MD', 'role': 'CONTACT', 'email': 'schweich@myocor.com', 'phone': '763 494 5400'}, {'name': 'Adam K Hoyhtya, MS', 'role': 'CONTACT', 'email': 'hoyhtya@myocor.com', 'phone': '763 494 5430'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myocor', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cyril J. Schweich, MD / VP of Clinical and Regulatory Affairs', 'oldOrganization': 'Myocor, Inc.'}}}}