Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-26 @ 12:11 PM
Study NCT ID:
NCT01528150
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2012-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aoza@sjm.com', 'phone': '+1 818 493 3648', 'title': 'Director Clinical Studies', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Data collection on adverse events were collected from Enrollment until 12M follow up, i.e. 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Accent MRI System', 'description': 'Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads', 'otherNumAtRisk': 466, 'otherNumAffected': 78, 'seriousNumAtRisk': 466, 'seriousNumAffected': 174}], 'otherEvents': [{'term': 'arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased right ventricular sensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'device programming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'exacerbation of heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma/bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'impedance out of range', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lead noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'musculoskeletal event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neurological event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other various', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other cardio/cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other lead related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker software issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac/Venous Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Helix issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hematoma/bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impedance out of range', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lead dislodgement or migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muskuloskeletal event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neoplastic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neurological event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other various', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Cardiac/cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other lead related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax/hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From RA and RV Lead-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Accent MRI System', 'description': 'Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads'}], 'classes': [{'title': 'Acute Timeframe (Implant to 2 Months)', 'categories': [{'measurements': [{'value': '97.19', 'groupId': 'OG000', 'lowerLimit': '94.94', 'upperLimit': '98.63'}]}]}, {'title': 'Chronic Timeframe (>2 Months to 12 Months)', 'categories': [{'measurements': [{'value': '99.14', 'groupId': 'OG000', 'lowerLimit': '97.58', 'upperLimit': '99.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months post-implant', 'description': 'Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Accent MRI System', 'description': 'Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Accent MRI System', 'description': 'Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.74', 'spread': '11.71', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '272', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'AtrioVentricular-Block (AV-Block)', 'classes': [{'title': 'No AV Block', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}]}]}, {'title': '1st Degree AV Block', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}, {'title': '2nd Degree AV Block', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}]}]}, {'title': '3rd Degree AV block', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sick Node Dysfunction', 'classes': [{'title': 'Sick Node Dysfunction', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}]}]}, {'title': 'No Sick Node Dysfunction', 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Neurocardiogenic Syncope', 'classes': [{'title': 'Previous Neurocardiogenic Syncope', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}, {'title': 'No Previous Neurocardiogenic Syncope', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 466}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2012-02-03', 'resultsFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-19', 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From RA and RV Lead-related Complications', 'timeFrame': 'up to 12 months post-implant', 'description': 'Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.', 'detailedDescription': 'Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an image. These include a static magnetic field, a time varying gradient magnetic field, and a radiofrequency field. All three of these fields interact with implanted devices and could create hazards for the device, the patient, or both. Due to these issues, currently marketed pacemaker systems may be contraindicated for use in an MRI environment.\n\nSt. Jude Medical has developed a system, the Accent MRI™ system, comprised of the Accent MRI™ device and the Tendril MRI™ lead, and an investigational MRI Activator™, designed to mitigate such interactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'standard bradycardia indications', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker\n* Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).\n* Is ≥ 18 years of age.\n* Able to provide written informed consent prior to any investigational related procedure.\n* Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.\n\nExclusion Criteria:\n\n* Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).\n* Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).\n* Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).\n* Have a lead extender, plug or adaptor.\n* Have a prosthetic tricuspid heart valve.\n* Are currently participating in another investigational device or drug investigation.\n* Are allergic to Dexamethasone sodium phosphate (DSP).\n* Are pregnant or planning to become pregnant during the duration of the study.\n* Have a life expectancy of less than 12 months from Screening due to any life-threatening condition'}, 'identificationModule': {'nctId': 'NCT01528150', 'acronym': 'TendrilMRI™', 'briefTitle': 'Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Clinical Investigation to Assess the Safety and Efficacy of the Tendril MRI™ Leads, as a Part of the Accent MRI™ System, in Patients With Standard Bradycardia Pacing Indication.', 'orgStudyIdInfo': {'id': 'CR-11-054-EU-LV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Accent MRI System', 'description': 'Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rob RW Breedveld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Center Leeuwarden, the Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}