Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2026-01-29 @ 3:59 PM
Study NCT ID:
NCT02096692
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2014-03-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ProMRI Study of the Iforia ICD System (Phase C)
Sponsor:
Organization:
Raw JSON
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Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'ICD System Therapy', 'description': 'Patients with a ProMRI ICD System\n\nPatients with a ProMRI ICD System: Tachycardia Fast Heart Beat\n\nMagnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine', 'otherNumAtRisk': 154, 'otherNumAffected': 24, 'seriousNumAtRisk': 154, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'MRI Incidental Finding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': 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finding from review of study MRI scan.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medication Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Pain or Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstructive Sleep Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope/Pre-Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Chronic Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ICD System Therapy', 'description': 'Patients with a ProMRI ICD System\n\nPatients with a ProMRI ICD System: Tachycardia Fast Heart Beat\n\nMagnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 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'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-01', 'studyFirstSubmitDate': '2014-03-24', 'resultsFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2014-03-25', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-18', 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate', 'timeFrame': '1 Month Post-MRI'}, {'measure': 'Percentage of Participants Free of Ventricular Pacing Threshold Rise', 'timeFrame': 'Between Pre-MRI and 1 Month Post-MRI', 'description': 'Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.'}, {'measure': 'Percentage of Participants Free of R-wave Sensing Attenuation', 'timeFrame': 'Between Pre-MRI and 1 Month Post-MRI', 'description': 'Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging']}, 'referencesModule': {'references': [{'pmid': '26049048', 'type': 'RESULT', 'citation': 'Awad K, Griffin J, Crawford TC, Lane Cox S, Ferrick K, Mazur A, Pena RE, Lloyd SG, Michalski J, Johnson W, Bailey WM. Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Oct;12(10):2155-61. doi: 10.1016/j.hrthm.2015.06.002. Epub 2015 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:\n\n* Age greater than or equal to 18 years\n* Able and willing to complete MRI testing\n* Able to provide written informed consent\n* Available for follow-up visit at the study site\n* Implanted with an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17.\n* ICD implanted pectorally\n* All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment\n* Underlying rhythm identifiable during sensing test\n* All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX)\n* Ventricular sensing is measurable and \\>6.5mV\n* Absence of phrenic nerve stimulation at 5.0V and 1.0 ms\n* Pacing impedance is between 200 and 1500 ohm\n* Shock Impedance is between 30 and 90 ohm\n* Able and willing to use the CardioMessenger II\n\nAt the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:\n\n* Absence of phrenic nerve stimulation at 5.0V @ 1.0 ms\n* \\|pacing 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