Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-10 @ 3:18 PM
Study NCT ID:
NCT05560958
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2022-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure setting (related to used BIOTRONIK EP products and competitor products)', 'timeFrame': 'Intervention', 'description': 'Type of procedure, type of catheter models, recording system, RF ablation generator, irrigation pump, stimulator, 3D system, patient cable'}, {'measure': 'Procedural parameters', 'timeFrame': 'Intervention', 'description': 'Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure'}, {'measure': 'Patient details', 'timeFrame': 'Baseline', 'description': 'demographics, medical history, and concomitant cardiovascular medication'}, {'measure': 'Device performance', 'timeFrame': 'Intervention', 'description': 'e.g., successful insertion and advancing of catheter, successful stimulation and recording of intracardiac signals, RF energy application, removal, replacement/substitution of catheter, device used within its intended purpose'}], 'primaryOutcomes': [{'measure': 'Rate of Device deficiencies', 'timeFrame': 'During EP procedure', 'description': 'Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons'}, {'measure': 'Rate of Peri-procedural adverse device effects for each investigational device type', 'timeFrame': 'Until or at 24-hour follow-up', 'description': 'Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up'}, {'measure': 'Rate of Post-procedural adverse device effects', 'timeFrame': 'After the 24-hour follow-up until or at the 3- to 6-month follow-up', 'description': 'Post-procedural adverse device effects that occur in the AlCath group after the 24-hour follow-up until or at the 3- to 6-month follow-up'}, {'measure': 'Percentage of Clinical benefit confirmations per number of use cases', 'timeFrame': 'At the time of procedure', 'description': 'Clinical benefit at the time of procedure for each investigational device type'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': "This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.", 'detailedDescription': "In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for diagnostic or therapeutic EP intervention\n* EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:\n\n * BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)\n * BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)\n * BIOTRONIK transseptal sheath (Senovo Bi-Flex)\n* BIOTRONIK EP product is planned to be used within its intended purpose\n* Ability to understand the nature of the study\n* Willingness to provide written informed consent\n* Ability and willingness to perform all follow-up visits at the study site\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Pregnant or breastfeeding\n* Prior participation in this study with performed EP procedure\n* Participation in an interventional clinical investigation in parallel to the BIO\\|COLLECT.EP study'}, 'identificationModule': {'nctId': 'NCT05560958', 'acronym': 'BIO|COLLECT-EP', 'briefTitle': 'Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products', 'orgStudyIdInfo': {'id': 'EP035'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)', 'type': 'DEVICE', 'description': 'Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '88048', 'city': 'Friedrichshafen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hansjörg Bauerle, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Städtisches Krankenhaus Friedrichshafen', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}], 'centralContacts': [{'name': 'Ines Danzke', 'role': 'CONTACT', 'email': 'ines.danzke@biotronik.com', 'phone': '+49 (0) 151 6890', 'phoneExt': '1352'}, {'name': 'Annette Thiem, Dr.', 'role': 'CONTACT', 'email': 'annette.thiem@biotronik.com', 'phone': '+49 (0) 151 6890', 'phoneExt': '1303'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will become available with uploading the results to clinical trial.gov. The data will be available as long as the study documents are archived.', 'ipdSharing': 'YES', 'description': 'Upon resonable request by authors or other scientifc reasons, but requires explicit approval by the sponsor.', 'accessCriteria': 'On demand; in case of request by an author or in case of scientific reasons, but requires explicit approval by the sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}