Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT00710567
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'whyStopped': 'Insufficient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2019-09-19', 'completionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2008-07-02', 'dispFirstSubmitQcDate': '2019-12-11', 'studyFirstSubmitQcDate': '2008-07-02', 'dispFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.', 'timeFrame': '180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'LVAS', 'LVAD', 'Rotary Pump'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge to cardiac transplantation.\n\nStudy Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.\n\nStudy Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe following are general criteria; more specific conditions are included in the study protocol:\n\n1. Approved for cardiac transplantation\n2. Listed with UNOS on the Status 1 list\n3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation\n\nExclusion Criteria:\n\nThe following are general criteria; more specific conditions are included in the study protocol:\n\n1. Contraindication to the administration of warfarin or anti-platelet agents\n2. Primary coagulopathy or platelet disorder\n3. Acute myocardial infarction within 48 hours prior to enrollment\n4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation\n5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device'}, 'identificationModule': {'nctId': 'NCT00710567', 'briefTitle': 'Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo Heart Inc.'}, 'officialTitle': 'Evaluation of the Safety and Effectiveness of the DuraHeart™ Left Ventricular Assist System in Patients Awaiting Transplantation', 'orgStudyIdInfo': {'id': 'DH003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Historical Data', 'description': 'DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients', 'interventionNames': ['Device: DuraHeart Left Ventricular Assist System (LVAS)']}], 'interventions': [{'name': 'DuraHeart Left Ventricular Assist System (LVAS)', 'type': 'DEVICE', 'otherNames': ['LVAD'], 'description': 'The DuraHeart LVAS is implanted in using open heart surgery', 'armGroupLabels': ['Historical Data']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "St. Joseph's Hospital of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapoils Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Aurora St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Francis D. Pagani, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Yoshifumi Naka, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'David S Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo Heart Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}