Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03021356
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2017-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of TrIfecta and Perimount Magna Ease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2017-01-08', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transprosthetic pressure gradient at stress exercise echocardiography', 'timeFrame': 'Echo at follow up stress echo (at 10 months)'}], 'secondaryOutcomes': [{'measure': 'Transprosthetic pressure gradient at discharge echo', 'timeFrame': 'Echo at discharge (usually postoperative day 5 to 7)'}, {'measure': 'Left ventricular mass regression calculated by echocardiography (gram)', 'timeFrame': 'Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)'}, {'measure': 'Quality of life using the EQ-5D-3L questionnaire', 'timeFrame': '1 to 5 days before surgery and at follow up (10 months)'}, {'measure': 'BNP plasma level', 'timeFrame': '1 to 5 days before surgery and at follow up (10 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Xenograft Hemodynamics']}, 'descriptionModule': {'briefSummary': "The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 75 years\n* Elective aortic valve replacement in patients with predominant aortic stenosis\n\n * including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement\n* Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.\n* Native German speakers (quality of life questionnaire in German language)\n\nExclusion Criteria:\n\n* Isolated aortic regurgitation\n* Concomitant aortic regurgitation \\> 2°\n* Endocarditis\n* LVEF \\<40%\n* Concomitant other valve surgery\n* s/p valve surgery\n* Contraindication for stress echocardiography'}, 'identificationModule': {'nctId': 'NCT03021356', 'briefTitle': 'Comparison of TrIfecta and Perimount Magna Ease', 'organization': {'class': 'OTHER', 'fullName': 'Kerckhoff Klinik'}, 'officialTitle': 'Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease', 'orgStudyIdInfo': {'id': 'COTRIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trifecta aortic xenograft', 'description': 'The Trifecta aortic xenograft is implanted in these patients.', 'interventionNames': ['Device: Aortic xenograft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magna Ease aortic xenograft', 'description': 'The Magna Ease aortic xenograft is implanted in these patients.', 'interventionNames': ['Device: Aortic xenograft']}], 'interventions': [{'name': 'Aortic xenograft', 'type': 'DEVICE', 'description': 'After randomization, the aortic xenograft is implanted in the standard fashion', 'armGroupLabels': ['Magna Ease aortic xenograft', 'Trifecta aortic xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kerckhoff Klinik', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}