Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
Study NCT ID:
NCT04473092
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2020-07-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphologic and functional changes of mitral valve anatomy', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': 'To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.', 'detailedDescription': 'Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who undergo TVMR for MR (age \\>18yrs) at the PI´s site', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• All patients who undergo TVMR for MR (age \\>18yrs) at the PI´s site\n\nExclusion Criteria:\n\n* \\<18yry\n* Subject does not provide full consent'}, 'identificationModule': {'nctId': 'NCT04473092', 'acronym': 'OneForAll', 'briefTitle': 'Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort', 'orgStudyIdInfo': {'id': '20-9223-BO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TMVR', 'type': 'DEVICE', 'description': 'Patients who undergo TMVR for MR at the PI´s site'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Essen, Westgerman Heart and Vascular Center, Department of Cardiology and Vascular Medicine', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Peter Lüdike, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Essen, Westgerman Heart- and Vascular Center, Department of Cardiology and Vascular Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Peter Lüdike', 'investigatorAffiliation': 'University Hospital, Essen'}}}}