Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT01460992
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-27', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary hypothesis 1: MRI and pacing system related Serious Adverse Device Effect (SADE) free rate', 'timeFrame': '3 months', 'description': 'MRI and pacing system related Serious Adverse Device Effect (SADE) Free-Rate is greater than 90%.'}, {'measure': 'Primary hypotheses 2 and 3: pacing threshold rise (atrial and ventricular)', 'timeFrame': '1 month', 'description': 'The atrial or ventricular MRI induced pacing threshold rise is not larger than or equal to 0.5 V between Pre-MRI and 1-month follow-up'}, {'measure': 'Primary hypothesis 4: P-wave sensing attenuation', 'timeFrame': '1 month', 'description': 'P-wave attenuation: P-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a P-wave amplitude at 1-month follow-up smaller or equal to 1.5 mV'}, {'measure': 'Primary hypothesis 5: R-wave sensing attenuation', 'timeFrame': '1 month', 'description': 'R-wave attenuation: R-wave amplitude decrease (between pre-MRI follow-up and 1-month follow-up) exceeding 50% or a R-wave amplitude at 1-month follow-up smaller or equal to 5.0 mV.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pacemaker therapy', 'Magnetic Resonance Imaging (MRI)', 'EVIA/ENTOVIS'], 'conditions': ['Cardiac Disease']}, 'referencesModule': {'references': [{'pmid': '25680307', 'type': 'DERIVED', 'citation': 'Bailey WM, Rosenthal L, Fananapazir L, Gleva M, Mazur A, Rinaldi CA, Kypta A, Merkely B, Woodard PK; ProMRI/ProMRI AFFIRM Study Investigators. Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Jun;12(6):1183-91. doi: 10.1016/j.hrthm.2015.02.010. Epub 2015 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'This investigation is designed to demonstrate the clinical safety of the EVIA/ ENTOVIS pacemaker system when used under specific MRI conditions.', 'detailedDescription': "In the past, MR scans were always contraindicated for pacemaker patients. If particular prerequisites and conditions are fulfilled, MR scans can now be conducted on patients with BIOTRONIK's EVIA/ENTOVIS pacemakers in combination with the Safio S pacemaker leads, scheduled to be part of this clinical study.\n\nThe specific MRI conditions for this investigation with the EVIA/ENTOVIS pacemaker family and Safio S pacemaker leads are defined in the study protocol"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_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* Pacemaker system consisting solely of the EVIA/ENTOVIS pacemaker and Safio S pacemaker leads\n* The pacemaker system has to be implanted, repositioned or exchanged at least 5 weeks prior to enrollment\n* Age more than 18 years\n* Understand the nature of the procedure\n* Able and willing to complete MRI testing\n* Able and willing to activate and use the Cardio Messenger\n* Give written informed consent\n* Able to complete all testing required by the clinical protocol\n* Ability to measure atrial and/or ventricular pacing threshold(s)\\* (at 0.4 ms)\n* All pacing thresholds do not exceed 2.0V @0.4ms.\n* Available for follow-up visit at the investigational site\n* Patient body height greater or equal to 140 cm\n* Pectoral implantation\n* The ascertained lead impedance is between 200 and 1500 Ohms.\n\nExclusion Criteria:\n\n* No EVIA/ENTOVIS /Safio S pacemaker system implanted\n* Pacing threshold(s) (at 0.4 ms) and sensing amplitudes are not measurable\n* Meet one or more of the contraindications\n* Being pregnant\n* Have a life expectancy of less than three months\n* Cardiac surgery already scheduled in the next three months\n* Enrolled in another cardiac clinical investigation\n* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, other active medical devices, non-MRI compatible devices (e.g. mechanical tricuspid valve)\n* Have other metallic artifacts/components in body that may interact with MRI'}, 'identificationModule': {'nctId': 'NCT01460992', 'acronym': 'ProMRIAFFIRM', 'briefTitle': 'ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker Leads', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Master Study for the MRI Compatibility of the EVIA/ENTOVIS Pacemaker in Combination With Safio S Pacemaker Lead', 'orgStudyIdInfo': {'id': '49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pacemaker therapy', 'description': 'Patients with an EVIA/ ENTOVIS pacemaker device. See inclusion and exclusion criteria.', 'interventionNames': ['Procedure: Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions']}], 'interventions': [{'name': 'Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions', 'type': 'PROCEDURE', 'otherNames': ['Evia/Entovis SR-T (single chamber with telemetry function), DR-T (dual chamber with telemetry function)', 'Atrial/ventricular lead(s): Safio S 53 and S 60.', 'Safio S 45'], 'description': 'patients will undergo an MRI scan for 30 minutes.', 'armGroupLabels': ['Pacemaker therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University Hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'St. Gertrauden Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dresden-Friedrichstadt', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Uniklinik Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Diakoniekrankenhaus Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Neuwied', 'country': 'Germany', 'facility': 'DRK Krankenhaus Neuwied', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Cardiology Department, St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Aldo Rinaldi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Cardiology Department, St Thomas' Hospital Lambeth Palace Road London, SE1 7EH United Kingdom E-mail: Aldo.Rinaldi@gstt.nhs.uk"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}