Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 5:57 AM
Study NCT ID:
NCT03179969
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The German Plug - Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality risk', 'timeFrame': 'five years', 'description': 'observation of the mortality risk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '40455223', 'type': 'DERIVED', 'citation': 'Konrad H, Werner N, Ouarrak T, Schofer J, Lubos E, Geist V, Eggebrecht H, Butter C, Schmitz T, Schafer U, Schumacher B, Schneider S, Zeymer U, Zahn R. Acute and long-term results of interventional treatment of paravalvular leaks after prosthetic valve replacement with plug devices: results from a prospective multicentre registry. Clin Res Cardiol. 2025 Jun 2. doi: 10.1007/s00392-025-02681-w. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk', 'detailedDescription': 'In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled "Deutsches Plug Register" The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register.\n\nIn this time, 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart valve replacement\n* Valve Replacement Leaks\n* Plug Device\n\nExclusion Criteria:\n\n* no written consent'}, 'identificationModule': {'nctId': 'NCT03179969', 'acronym': 'PLUG', 'briefTitle': 'The German Plug - Registry', 'organization': {'class': 'OTHER', 'fullName': 'Stiftung Institut fuer Herzinfarktforschung'}, 'officialTitle': 'Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry', 'orgStudyIdInfo': {'id': 'PLUG Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paravalvular leak', 'type': 'OTHER', 'description': 'Observational study on patients with paravalvular leak'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67063', 'city': 'Ludwigshafen', 'state': 'Deutschland', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}], 'overallOfficials': [{'name': 'Ralf Zahn, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Ludwigshafen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}