Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-28 @ 3:39 PM
Study NCT ID:
NCT02506569
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProMRI 3T ENHANCED Master Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2015-07-14', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Device Effect (SADE)-free rate of implantable cardioverter defibrillators and leads possibly or securely related to the MRI procedure', 'timeFrame': '1 Month'}, {'measure': 'Increase in pacing thresholds ratios measured between 1-month post-MRI and pre-MRI', 'timeFrame': '1 Month', 'description': 'Evaluate the percentage of ICD leads with an increase in the pacing threshold ratio measured between the Pre-MRI and 1-month post-MRI'}, {'measure': 'Decrease in sensing amplitude ratios between 1-month post-MRI and pre-MRI', 'timeFrame': '1 Month', 'description': 'Evaluate the percentage of ICD leads with a decrease in the sensing amplitude ratio measured between the Pre-MRI and 1-month post-MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Safety of MR (Magnetic Resonance)-Conditional ICDs']}, 'descriptionModule': {'briefSummary': "The investigation is designed to provide supporting evidence for the clinical safety of the Biotronik's new Implantable Cardioverter Defibrillator systems when used under specific 3 Tesla MR conditions ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The patients selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Implanted with Implantable Cardioverter Defibrillator (ICD) system according to Clinical Investigational Plan (CIP)\n* ICD system was implanted in the pectoral region\n* Implantation at least 5 weeks prior to enrollment date\n* Patient body height ≥ 140 cm\n* Age ≥ 18 years\n* Right Ventricular pacing threshold (at 0.4 ms) measurable and ≤ 2.0 V\n* Written informed consent\n* Able and willing to complete MRI testing\n* Able and willing to complete all testing required by the clinical protocol\n* Available for all follow-up visits at the investigational site\n\nExclusion Criteria:\n\n* Standard contraindication for MRI scans\n* Patient shows signs of a twiddler's syndrome, i.e. fiddles with implant\n* Explantation, exchange or reposition of ICD or lead within 5 weeks prior to enrollment date\n* Charging status of the battery is Elective Replacement Indicator (ERI) or End of Service (EOS)\n* MRI scan within 5 weeks prior to enrollment date\n* R-wave sensing amplitude \\< 6.5 millivolt\n* Lead impedance less than 200 or greater than 1500 Ohm\n* Life expectancy of less than six months\n* Cardiac surgery in the next six months\n* Pregnant or breastfeeding\n* Participation in another interventional clinical investigation"}, 'identificationModule': {'nctId': 'NCT02506569', 'briefTitle': 'ProMRI 3T ENHANCED Master Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'ProMRI 3T ENHANCED Master Study', 'orgStudyIdInfo': {'id': 'TA109'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantable Cardioverter Defibrillator therapy', 'type': 'DEVICE', 'description': 'Tachycardia Fast Heart Beat'}, {'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'OTHER', 'description': 'MRI scan of the head and lower body parts'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bedford Park', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Sydney', 'country': 'Australia', 'facility': 'Royal North Shore Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Westmead', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Landesklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Uniklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Lingen', 'country': 'Germany', 'facility': 'St. Bonifatius Hospital', 'geoPoint': {'lat': 52.52143, 'lon': 7.31845}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Heart Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Rainer Zbinden, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Triemli Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}