Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-04 @ 12:45 PM
Study NCT ID:
NCT02536118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micra Transcatheter Pacing System Post-Approval Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia', 'Slovenia', 'United Arab Emirates']}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3100}, 'targetDuration': '9 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Micra System complications, pacing impedance (ohms) and pacing threshold (volts), following exposure to MR environment', 'timeFrame': 'Up to 9 years', 'description': 'Micra System performance will be described following use in an MR environment. A listing of MRI related events, pacing impedance (ohms) and pacing threshold (volts) over time following MR exposure may be reported.'}], 'primaryOutcomes': [{'measure': 'Acute complication rate', 'timeFrame': '30-days', 'description': 'To estimate acute complication rate related to the Micra system and/or implant procedure.'}, {'measure': 'Long-term complication free survival', 'timeFrame': '9 years', 'description': 'To estimate the chronic complication free survival rate of the Micra system.'}], 'secondaryOutcomes': [{'measure': 'Pacing impedance (ohms) and pacing threshold (volts)', 'timeFrame': 'Up to 9 years', 'description': 'Summary statistics of electrical performance 5-years post-implant measurements will be reported.'}, {'measure': 'Complications stratified by implant type', 'timeFrame': 'Up to 9 years', 'description': 'A listing of Micra system and/or implant procedure related complications stratified by implant types including de novo implants, previous cardiac device, or co-existing hardware. The listing will include complications will be listed including device implant date, complication category, complication date, device-relatedness and seriousness.'}, {'measure': 'Estimate Micra System revision rate', 'timeFrame': 'Up to 9 years', 'description': 'Summary statistics post-implant Micra System revisions, including system explant, replacement (with and without system explant), reposition will be reported.'}, {'measure': 'Estimate System Longevity', 'timeFrame': 'Up to 9 years', 'description': 'Summary statistics regarding battery length will be reported.'}, {'measure': 'Confirm the rate response operation of the Micra system', 'timeFrame': 'Approximately 2 years', 'description': 'Analysis of treadmill testing data from patients implanted with Micra for at least 3 months. Rate response data collected in the registry will be combined with data from the FDA Investigational Device Exemption study (NCT 02004873).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bradycardia']}, 'referencesModule': {'references': [{'pmid': '35025987', 'type': 'DERIVED', 'citation': 'Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.'}, {'pmid': '34757189', 'type': 'DERIVED', 'citation': 'El-Chami MF, Garweg C, Iacopino S, Al-Samadi F, Martinez-Sande JL, Tondo C, Johansen JB, Prat XV, Piccini JP, Cha YM, Grubman E, Bordachar P, Roberts PR, Soejima K, Stromberg K, Fagan DH, Clementy N. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2022 Feb;19(2):228-234. doi: 10.1016/j.hrthm.2021.10.023. Epub 2021 Oct 29.'}, {'pmid': '33428248', 'type': 'DERIVED', 'citation': 'El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.'}, {'pmid': '32763431', 'type': 'DERIVED', 'citation': 'Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.'}, {'pmid': '30103071', 'type': 'DERIVED', 'citation': 'El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Vinolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.\n\nThe Micra Registry is conducted within Medtronic\'s Product Surveillance Registry.', 'detailedDescription': "The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry\\*.\n\nEnrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.\n\n\\*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients intended to be implanted with a Micra system are eligible for enrollment and all patients must be consented prior to the implant. Only geographies with regulatory approval for the Micra system are eligible to enroll patients (see locations section).\n\nAll patients enrolled and successfully implanted with a Micra system will be followed for a minimum of 9 years, unless a patient is exited from the registry due to an unavoidable reason. If a Micra system is not successfully implanted, patients will be exited from the registry unless a Micra System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements\n* Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results'}, 'identificationModule': {'nctId': 'NCT02536118', 'briefTitle': 'Micra Transcatheter Pacing System Post-Approval Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Micra Transcatheter Pacing System Post-Approval Registry', 'orgStudyIdInfo': {'id': 'Micra Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients implanted with Micra System', 'description': 'Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.', 'interventionNames': ['Device: Micra Transcatheter Pacing System']}], 'interventions': [{'name': 'Micra Transcatheter Pacing System', 'type': 'DEVICE', 'otherNames': ['Micra', 'Micra TPS'], 'description': 'The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.', 'armGroupLabels': ['Patients implanted with Micra System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'city': 'Takoma Park', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.97789, 'lon': -77.00748}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 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