Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04227002
Status:
RECRUITING
Last Update Posted:
2020-01-13
First Post:
2020-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hamburg AoRtic Valve cOhoRt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2049-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'one year', 'description': 'The primary aim of the study is to investigate all cause mortality after surgical aortic valve replacement or transcatheter aortic valve replacement. Events of death will be registered either from in-house information or telephone follow-up of the patient or the referring physician as part of clinical routine.'}], 'secondaryOutcomes': [{'measure': 'Myocardial Infarction', 'timeFrame': '30 days after index procedure', 'description': 'Myocardial infarction based on a combination of clinical criteria, ecg changes indicative of new ischemia and a significant rise in cardiac biomarkers (peak value exceeding 15 x as the upper reference limit for troponin or 5 x for CK-MB) within the first 72 hours (periprocedural myocardial infarction) or 30 days (spontaneous myocardial infarction) after index procedure'}, {'measure': 'Stroke', 'timeFrame': '30 days after procedure', 'description': 'Assessment of clinical disability using a modified Rankin Scale (mRS) within the first 30 days after index procedure'}, {'measure': 'Vascular complications and bleeding', 'timeFrame': '30 days after procedure', 'description': 'Evaluation of overt bleeding or vascular complications after index procedure by drop in haemoglobin and transfusion of packed red blood cells'}, {'measure': 'Durability of the implanted aortic valve prosthesis', 'timeFrame': '10 years', 'description': 'Evaluation of long time durability of the implanted aortic valve prosthesis by echocardiography in the yearly follow up.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '34156524', 'type': 'DERIVED', 'citation': 'Westermann D, Ludwig S, Kalbacher D, Spink C, Linder M, Bhadra OD, Nikorowitsch J, Waldschmidt L, Demal T, Voigtlander L, Schaefer A, Seiffert M, Pecha S, Schofer N, Greenbaum AB, Reichenspurner H, Blankenberg S, Conradi L, Schirmer J. Prevention of coronary obstruction in patients at risk undergoing transcatheter aortic valve implantation: the Hamburg BASILICA experience. Clin Res Cardiol. 2021 Dec;110(12):1900-1911. doi: 10.1007/s00392-021-01881-4. Epub 2021 Jun 22.'}]}, 'descriptionModule': {'briefSummary': "The primary aim of the study is to identify the optimal treatment modality for patients with aortic valve disease, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion.", 'detailedDescription': "Patients with severe aortic valve disease have a poor prognosis under medical therapy, making replacement of the failing valve the preferred option. In addition to surgical aortic valve replacement (SAVR), transcatheter aortic valve implantation (TAVI) has evolved as an alternative treatment option for patients at intermediate and high operative risk. Before expansion of TAVI to low-risk and younger patients can be recommended, several questions remain to be investigated, e.g. optimal patient selection, periprocedural complications and long-term durability. Therefore every patient with a relevant aortic valve disease (aortic stenosis, aortic regurgitation or degenerative aortic valve prosthesis) who meets the inclusion/exclusion criterias is planned to be involved in the study.\n\nPredictors of outcome are yet to be defined in patients with aortic valve disease in order to improve risk prediction for the different treatment modalities (medical, SAVR, TAVI).\n\nThe primary aim of the study is to identify the optimal treatment modality for the individual patient, incorporating the individual patient's risk profile and anticipated clinical outcomes. This includes the association of demographic factors, procedural data and biomarkers with clinical outcome in a prospective fashion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The medical condition being studied is aortic valve disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically relevant aortic valve disease (aortic valve stenosis, aortic regurgitation, degenerated aortic valve prosthesis)\n* Written informed consent\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language (able to understand and write the German language)\n* Physical or psychological incapability to take part in the investigation'}, 'identificationModule': {'nctId': 'NCT04227002', 'acronym': 'HARbOR', 'briefTitle': 'Hamburg AoRtic Valve cOhoRt', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Clinical Cohort Study - Hamburg AoRtic Valve cOhoRt', 'orgStudyIdInfo': {'id': 'HARbOR'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Moritz Seiffert, MD', 'role': 'CONTACT', 'email': 'm.seiffert@uke.de', 'phone': '+49407410', 'phoneExt': '58206'}, {'name': 'Moritz Seiffert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitäres Herz- und Gefäßzentrum', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Moriz Seiffert, MD', 'role': 'CONTACT', 'email': 'm.seiffert@uke.de', 'phone': '+49407410', 'phoneExt': '58206'}, {'name': 'Niklas Schofer, MD', 'role': 'CONTACT', 'email': 'n.schofer@uke.de', 'phone': '+49407410', 'phoneExt': '58206'}], 'overallOfficials': [{'name': 'Moritz Seiffert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heart Center Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}