Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 3:20 AM
Study NCT ID:
NCT04735666
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2300}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CIED infections', 'timeFrame': 'three months', 'description': 'CIED infections occurring in an observation period of three months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.'}], 'secondaryOutcomes': [{'measure': 'CIED infections', 'timeFrame': '12 months', 'description': 'CIED infections occurring in an observation period of 12 months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.'}, {'measure': 'CIED infections', 'timeFrame': '36 months', 'description': 'CIED infections occurring in an observation period of 36 months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.'}, {'measure': 'AE', 'timeFrame': '3, 12 and 36 months', 'description': 'Adverse events (complications) during 3, 12 and 36 months follow-up'}, {'measure': 'All-cause mortality', 'timeFrame': '3, 12 and 36 months', 'description': 'Allcause mortality during 3, 12 and 36 months follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CIED Related Infection']}, 'referencesModule': {'references': [{'pmid': '39367427', 'type': 'DERIVED', 'citation': 'Vonthein R, Baldauf B, Borov S, Lau EW, Giaccardi M, Assadian O, Haddad C, Chevalier P, Bode K, Foley P, Thomas H, Campbell NG, Fichtner S, Donazzan L, Pescoller F, Oberhollenzer R, Cemin R, Bonnemeier H. Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace registry. J Cardiothorac Surg. 2024 Oct 4;19(1):592. doi: 10.1186/s13019-024-03059-1.'}], 'seeAlsoLinks': [{'url': 'http://www.etpr.eu', 'label': 'domain of the EuropeanTauroPace Registry'}]}, 'descriptionModule': {'briefSummary': 'University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).', 'detailedDescription': 'This study is performed as an all-case investigation. The treatment is performed based on the SOPs (Appendix Study Protocol). The standard observation period is 3 months from the 1st treatment. Safety and effectiveness are evaluated at 3rd and 12th month. In addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as CIED treatment continues. When the treatment ends (extraction of all hardware), observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique Case Report Form (CRF) system. The duration of the study is estimated at 10 years (registry).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consist of every subsequent participant eligible for any CIED related surgery with TauroPace™', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)\n* Participant is eligible for a CIED related surgery procedure.\n\nExclusion Criteria:\n\n* Age\\<18years\n* Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.'}, 'identificationModule': {'nctId': 'NCT04735666', 'acronym': 'ETPR', 'briefTitle': 'European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study', 'orgStudyIdInfo': {'id': '1.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TauroPace™', 'type': 'DEVICE', 'description': 'TauroPace™ is intended to be used as a disinfecting solution during any CIED related surgery procedure or handling of any uncoated or silicon-, epoxy- or polyurethane-coated CIED (including its components, e.g., leads) made of titan or stainless steel in any adult patient requiring or carrying a CIED.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2700', 'city': 'Wiener Neustadt', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Ojan Assadian, Prof.', 'role': 'CONTACT', 'email': 'Ojan.Assadian@wienerneustadt.lknoe.at'}, {'name': 'Alexander Teubl, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ojan Assadian, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Landeskrankenhaus Wiener Neustadt', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '69500', 'city': 'Lyon', 'state': 'Bron', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Chevalier, PhD', 'role': 'CONTACT', 'email': 'philippe.chevalier@chu-lyon.fr'}], 'facility': 'Louis Pradel Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '84036', 'city': 'Landshut', 'state': 'Bavaria', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Krankenhaus Landshut Achdorf', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'zip': '27474', 'city': 'Cuxhaven', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hendrik Bonnemeier, PhD', 'role': 'CONTACT', 'email': 'bonnemeier@t-online.de'}, {'name': 'Clinician Scientist, MD', 'role': 'CONTACT', 'email': 'sportmedic@gmail.com'}], 'facility': 'Helios Klinik Cuxhaven', 'geoPoint': {'lat': 53.86828, 'lon': 8.69902}}, {'zip': '26954', 'city': 'Nordenham', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hendrik Bonnemeier, PhD', 'role': 'CONTACT', 'email': 'bonnemeier@t-online.de'}, {'name': 'Clinician Scientist, MD', 'role': 'CONTACT', 'email': 'sportmedic@gmail.com'}], 'facility': 'Helios Klinik Wesermarsch', 'geoPoint': {'lat': 53.50098, 'lon': 8.48965}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'status': 'COMPLETED', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '39100', 'city': 'Bolzano', 'state': 'Trentino-Alto Adige', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Cemin, MD', 'role': 'CONTACT', 'email': 'ROBERTO.CEMIN@sabes.it'}], 'facility': 'Ospedale Regionale San Maurizio', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'zip': 'SN3 6BB', 'city': 'Swindon', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United Kingdom', 'facility': 'Great Western Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}], 'centralContacts': [{'name': 'Clinician scientist, MD', 'role': 'CONTACT', 'email': 'sportmedic@gmail.com', 'phone': '+11-49-17696450666'}, {'name': 'Jana Henke', 'role': 'CONTACT', 'email': 'henke.jana@gmx.de'}], 'overallOfficials': [{'name': 'Hendrik Bonnemeier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kiel - Medical Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'participant data is recorded in a pseudonymous manner in the centre, before statistical analysis data is anonymized'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Luebeck', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator ETPR', 'investigatorFullName': 'Prof. Dr. Hendrik Bonnemeier', 'investigatorAffiliation': 'University of Kiel'}}}}