Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT03024268
Status:
UNKNOWN
Last Update Posted:
2021-05-10
First Post:
2016-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Acute changes in right and left ventricular pressures during interventionell ASD closure', 'timeFrame': 'immediately before and immediately after ASD closure'}], 'primaryOutcomes': [{'measure': 'Change in Exercise tolerance: 6 minute walking test', 'timeFrame': 'baseline, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in New York Heart Association Functional Classification assessment', 'timeFrame': 'baseline, 3 and 6 months', 'description': 'Changes in New York Heart Association Functional Classification'}, {'measure': 'Changes in Echocardiography: bi ventricular function (2D and 3D)', 'timeFrame': 'baseline, 3 and 6 months'}, {'measure': 'Changes in Echocardiography: assessment of left atrium (2D and 3D)', 'timeFrame': 'baseline, 3 and 6 months'}, {'measure': 'Changes in Echocardiography: assessment of heart valves', 'timeFrame': 'baseline, 3 and 6 months'}, {'measure': 'Changes in Echocardiography: strain using speckle tracking', 'timeFrame': 'baseline, 3 and 6 months'}, {'measure': 'Changes in Echocardiography: evaluation of iatrogenic ASD (2D and 3D)', 'timeFrame': 'baseline, 3 and 6 months'}, {'measure': 'Heart insufficiency bio markers', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Changes in Cardiac MRI: bi ventricular function', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Changes in Cardiac MRI: left ventricular longitudinal strain', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Changes in Cardiac MRI: left ventricular circumferential strain', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Changes in Cardiac MRI: flow measurements in main pulmonary artery and aorta', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Evaluation of hospitalisation rate', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': 'Telephone'}, {'measure': 'Evaluation of mortality', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': 'Telephone'}, {'measure': 'Combined endpoint (hospitalisation and mortality)', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': 'Telephone; Combined Endpoint of hospitalisation and mortality. For analysis the first event is counted regardless of severity.'}, {'measure': 'Changes in quality of life in "Minnesota Living with Heart Failure" questionnaire', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Changes in quality of life in "Short Form - 36" questionnaire', 'timeFrame': 'baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mitral Valve Insufficiency', 'Heart Septal Defects, Atrial']}, 'referencesModule': {'references': [{'pmid': '36371488', 'type': 'DERIVED', 'citation': 'Blazek S, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Rosch S, Daehnert I, Thiele H, Lurz P, von Roeder M. Fate of iatrogenic atrial septal defects following mitral transcatheter edge-to-edge repair - a subanalysis of the MITHRAS trial. Int J Cardiovasc Imaging. 2023 Mar;39(3):519-530. doi: 10.1007/s10554-022-02750-5. Epub 2022 Nov 13.'}, {'pmid': '34949392', 'type': 'DERIVED', 'citation': 'Lurz P, Unterhuber M, Rommel KP, Kresoja KP, Kister T, Besler C, Fengler K, Sandri M, Daehnert I, Thiele H, Blazek S, von Roeder M. Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2685-2694. doi: 10.1016/j.jcin.2021.09.023.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this prospective trial is to assess the hemodynamic effects of a MitraClip procedure caused iatrogenic arterial septal defect (iASD) and the functional changes after interventional iASD closure in a randomized setting.', 'detailedDescription': 'Transcatheter mitral valve repair with the MitraClip system is a therapeutic alternative to surgery in selected high-risk patients. Clip placement requires interatrial transseptal puncture and meticulous manipulation of the steerable sheath. There is evidence that the persistence of a relevant iASD after MitraClip is associated with worse clinical outcomes and increased mortality.\n\nThe purpose of this study is to investigate, if the interventional closure of an persistant hemodynamic relevant iASD 30 days after MitraClip implantation, has favorable effects on clinical outcome. Eligible patients, after obtaining written informed consent, are 1:1 randomized either in group A (interventional occlusion of iASD) or group B (best supportive care).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Previous MitraClip implantation\n* Persistent relevant iASD 30 days after MitraClip intervention\n\nExclusion Criteria:\n\n* Unsuccessful MitraClip implantation\n* No relevant iASD 30 days after MitraClip intervention\n* Unstable angina in the previous 4 weeks\n* Valvular heart disease (aortic, tricuspid or pulmonary valve) planed for surgery or interventional therapy\n* Constrictive pericarditis / restrictive cardiomyopathies\n* Pericardial effusion planed for surgery or interventional therapy\n* Coagulation disorders\n* Malignant disease with a life expectance \\< 12 months\n* Pregnancy\n* Participation in another study\n* iASD diameter \\> 38 mm\n* Aortic minimum distance of the iASD \\< 5 mm\n* Thrombus in left atrial appendage\n* Venous access impossible with a 24 French catheter system\n* Presence of an inferior vena cava filter'}, 'identificationModule': {'nctId': 'NCT03024268', 'briefTitle': 'MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'MitraClip® and Hemodynamic Effects of Relevant Iatrogenic Atrial Septum Defect Closure - Evaluation of Morphologic and Functional Changes in a Randomized Setting', 'orgStudyIdInfo': {'id': 'MITHRAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: interventional closure of iASD', 'description': 'Interventional closure of iASD (n=40) with an Figulla Flex Occluder (Occlutech)', 'interventionNames': ['Device: Figulla Flex Occluder (Occlutech)']}, {'type': 'NO_INTERVENTION', 'label': 'B: no intervention', 'description': 'Best medical supportive care (n=40)'}], 'interventions': [{'name': 'Figulla Flex Occluder (Occlutech)', 'type': 'DEVICE', 'description': 'Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)', 'armGroupLabels': ['A: interventional closure of iASD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center of the University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Philipp Lurz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center of the University Leipzig'}, {'name': 'Stephan Blazek, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Center of the University Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Investigator, Professor, Managing Senior Physician', 'investigatorFullName': 'Philipp Lurz', 'investigatorAffiliation': 'Heart Center Leipzig - University Hospital'}}}}