Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 12:53 PM
Study NCT ID:
NCT04035356
Status:
TERMINATED
Last Update Posted:
2024-08-09
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HAART Annuloplasty Device Valve Repair Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'The study will be merged with another one.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NYHA Functional Classification', 'timeFrame': '10 years', 'description': 'New York Hospital Association (NYHA) class:\n\n* Class I: cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.\n* Class II: cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.\n* Class III: cardiac disease resulting in marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.\n* Class IV: cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.'}, {'measure': 'Aortic valve regurgitation grade', 'timeFrame': '10 years', 'description': 'The severity of aortic valve regurgitation expressed as the aortic regurgitation (AR) Grade (or Aortic insufficiency (AI) Grade). The grades are defined by the American Society of Echocardiography guidelines based on regurgitant volume (RVol), regurgitant fraction (RF), and effective regurgitant orifice area (EROA), and expressed as:\n\n0 (None/trace)\n\nI (Mild: RVol \\<30 mL, RF \\<30%, EROA \\<0.1 cm\\*\\*2)\n\nII (Mild-Moderate: RVol 30-44 mL, RF 30-39%, EROA 0.1-0.19 cm\\*\\*2)\n\nIII (Moderate-Severe: RVol 45-59 mL, RF 40-49%, EROA 0.20.29 cm\\*\\*2)\n\nIV (Severe: RVol ≥60 mL, RF ≥50%, EROA ≥0.3 cm\\*\\*2).'}, {'measure': 'Freedom from Cardiovascular Events', 'timeFrame': '10 years', 'description': 'Occurrence of any of the following events will be considered failure on this outcome measure.\n\n* Cardiac-related death\n* Aortic valve reintervention/reoperation\n* Major bleeding event\n* Structural valve deterioration\n* Nonstructural dysfunction\n* Operated valve endocarditis\n* Valve thrombosis\n* New permanent pacemaker or defibrillator within 14 days after the valve intervention\n* Embolism'}, {'measure': 'All cause mortality', 'timeFrame': '10 years', 'description': 'Death due to any cause'}, {'measure': 'Noncardiovascular serious adverse events', 'timeFrame': '10 years', 'description': 'Adverse events not of cardiovascular nature that led to death, resulted in a life-threatening illness or injury, resulted in hospitalization, or resulted in persistent or significant disability/incapacity.'}], 'primaryOutcomes': [{'measure': 'Freedom from aortic valve reoperation', 'timeFrame': '10 years', 'description': 'A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['aortic valve repair', 'aortic valve annuloplasty'], 'conditions': ['Aortic Valve Insufficiency', 'Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '26156945', 'type': 'BACKGROUND', 'citation': 'Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.'}, {'pmid': '25865762', 'type': 'BACKGROUND', 'citation': 'Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.'}, {'pmid': '30138245', 'type': 'BACKGROUND', 'citation': 'Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Pirk J, Pfeiffer S, Wei LM, Badhwar V. Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results. Innovations (Phila). 2018 Jul/Aug;13(4):248-253. doi: 10.1097/IMI.0000000000000539.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting.', 'detailedDescription': 'The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm.\n\nThe study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device at participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.\n* The patient has reviewed and signed the written informed consent form.\n* The patient agrees to return for all follow-up evaluations for the duration of the study.\n\nExclusion Criteria:\n\n* Retrospective patient that has undergone a subsequent aortic valve replacement procedure.'}, 'identificationModule': {'nctId': 'NCT04035356', 'briefTitle': 'HAART Annuloplasty Device Valve Repair Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biostable Science & Engineering'}, 'officialTitle': 'Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study', 'orgStudyIdInfo': {'id': 'TP-01-045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAART 300', 'description': 'HAART 300 Aortic Annuloplasty Device', 'interventionNames': ['Device: Aortic valve repair']}, {'label': 'HAART 200', 'description': 'HAART 200 Aortic Annuloplasty Device', 'interventionNames': ['Device: Aortic valve repair']}], 'interventions': [{'name': 'Aortic valve repair', 'type': 'DEVICE', 'description': 'Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery', 'armGroupLabels': ['HAART 200', 'HAART 300']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan Health Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Heart & Vascular institute', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'J. Scott Rankin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University Heart and Vascular Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biostable Science & Engineering', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}