Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-28 @ 7:40 AM
Study NCT ID:
NCT04096859
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PremiCron Suture for Cardiac Valve Repair
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': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a composite endpoint of Myocardial infarction, Stroke, Mortality until discharge and rate of Endocarditis of the replaced / reconstructed valve until 6 months', 'timeFrame': 'from intervention up to 6 months postoperative', 'description': 'a composite endpoint of\n\n* Myocardial infarction until discharge\n* Stroke until discharge\n* Mortality until discharge\n* Endocarditis of the replaced / reconstructed valve until 6 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of mortality at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of mortality until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of myocardial infarction (MI) at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of myocardial infarction (MI) until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of stroke at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of stroke until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of endocarditis of the replaced / reconstructed valve at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of endocarditis of the replaced / reconstructed valve until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of superficial and deep chest wound infections valve at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of superficial and deep chest wound infections until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of atrial fibrillation valve at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of atrial fibrillation until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of renal failure at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of renal failure until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of pneumonia at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of pneumonia until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of mediastinitis at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of mediastinitis until discharge, 30 days and 6 months postop'}, {'measure': 'Comparison of bleeding at different timepoints in postoperative course', 'timeFrame': 'until discharge (approximately 10 days postoperative), 30 days and 6 months postop', 'description': 'Incidence of bleeding until discharge, 30 days and 6 months postop'}, {'measure': 'Rate of adverse events', 'timeFrame': 'until 6 months postop', 'description': 'valve related reoperation, haemothorax, paravalvular leak, pacemaker insertion, embolism, valve insufficiency, gastrointestinal bleeding, surgery not valve related'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'until discharge (approximately 10 days postoperative)', 'description': 'Number of days the patient has to stay in intensive care unit after intervention'}, {'measure': 'Length of hospital stay', 'timeFrame': 'until discharge (approximately 10 days postoperative)', 'description': 'Number of days the patient has to stay in hospital'}, {'measure': 'Intraoperative handling of the suture material', 'timeFrame': 'intraoperative', 'description': 'Intraoperative handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale), including pledget assessment'}, {'measure': 'Course of Health Status', 'timeFrame': 'until 6 months postoperative', 'description': 'EQ-5D is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"'}, {'measure': 'Employment status', 'timeFrame': 'preoperative and 6 months postoperative', 'description': 'The employment status of the patient before / after the intervention to evaluate the influence of cardiac valve reconstruction or / and replacement on employment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elective surgery', 'minimally invasive surgery', 'cardiac valve reconstruction', 'cardiac valve replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '37113912', 'type': 'RESULT', 'citation': 'Rufa M, Ursulescu A, Baumann P, Ferrer MT. A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery - PREMIVALVE a cohort study. Ann Med Surg (Lond). 2023 Apr 4;85(4):835-841. doi: 10.1097/MS9.0000000000000442. eCollection 2023 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement.\n* Age ≥18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery.\n* Emergency surgery\n* Pregnancy\n* Infective endocarditis\n* Previous cardiac surgical intervention\n* Known immunodeficiency or immunosuppression\n* Participation or planned participation in another cardiovascular study before study follow-up is completed.\n* Inability to give informed consent due to mental condition, mental retardation, or language barrier.'}, 'identificationModule': {'nctId': 'NCT04096859', 'acronym': 'PremiValve', 'briefTitle': 'PremiCron Suture for Cardiac Valve Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Assessment of PremiCron Suture for Cardiac Valve Reconstruction and Replacement. A Multi-centric, Prospective, Single Arm Observational Study in Daily Practice.', 'orgStudyIdInfo': {'id': 'AAG-O-H-1823'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PremiCron®', 'description': 'Assessment of PremiCron suture for cardiac valve reconstruction and replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert Bosch KH Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Ulrich FW Franke, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Bosch KrankenhausDepartment for Thoracic and Vascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}