Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-31 @ 5:51 AM
Study NCT ID:
NCT03624504
Status:
COMPLETED
Last Update Posted:
2020-09-30
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
China Micra Transcatheter Pacing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}}}}, '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': 'weifan.sun@medtronic.com', 'phone': '021-20325267', 'title': 'Weifan Sun, Clinical Study Manager', 'phoneExt': '86', 'organization': 'Medtronic (Shanghai) Management Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From implant attempt to last subject follow-up, ranging from 0 to 14 months', 'description': 'Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).', 'eventGroups': [{'id': 'EG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 8, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatic angiosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Major Complications Free Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '99.4'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000'], 'paramType': 'Kaplan-Meier survival probability (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.6', 'ciLowerLimit': '90.6', 'ciUpperLimit': '99.4', 'pValueComment': 'The threshold for significance was 0.05.', 'estimateComment': 'The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.', 'groupDescription': 'Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%\n\nAlternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%.', 'statisticalMethod': 'z test, 1-sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months post implant', 'description': 'Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pacing Capture Threshold (PCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'classes': [{'title': 'Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'Pacing capture threshold @0.24ms pulse width Capture threshold is defined as the minimum electrical stimulus required to consistently capture the heart outside of the myocardial refractory period.\n\nPulse width is the duration of the current flow expressed in milliseconds. The pulse width must be long enough for depolarization to disperse to the surrounding tissue.', 'unitOfMeasure': 'Volts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '81 subjects with successful implant were eligible at follow up for this data. One subject at Month 1 did not have the PCT completed, so the data is not summarized below.'}, {'type': 'SECONDARY', 'title': 'Impedance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'classes': [{'title': 'Implant', 'categories': [{'measurements': [{'value': '873.83', 'spread': '228.26', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'categories': [{'measurements': [{'value': '781.73', 'spread': '193.85', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '719.38', 'spread': '142.27', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'categories': [{'measurements': [{'value': '659.01', 'spread': '130.04', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'categories': [{'measurements': [{'value': '632.22', 'spread': '124.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'Impedance measured from the Micra device Impedance is the opposition to current flow.', 'unitOfMeasure': 'Ohms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '81 subject with successful implant'}, {'type': 'SECONDARY', 'title': 'Sensing Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'classes': [{'title': 'Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.41', 'spread': '3.87', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.16', 'spread': '3.88', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.53', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': '3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.78', 'spread': '4.05', 'groupId': 'OG000'}]}]}, {'title': '6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.87', 'spread': '4.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'R-wave sensing amplitude measured from the Micra device Sensing is the ability of the pacemaker to "see" when a natural (intrinsic) depolarization is occurring.', 'unitOfMeasure': 'mV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '81 subjects with successful implant were eligible at follow up for this data. One subject at Month 1 did not have the R-wave sensing amplitude completed, so the data is not summarized below.'}, {'type': 'SECONDARY', 'title': 'Adverse Device Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'classes': [{'title': 'Anaemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Arteriovenous fistula', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bundle branch block right', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chest pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Deep vein thrombosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Device pacing issue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial necrosis marker increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Oedema peripheral', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Troponin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Ventricular extrasystoles', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From implant attempt to last subject follow-up, ranging from 0 to 14 months', 'description': 'Adverse event related to the Micra system or implant procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with an implant attempt'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Unsuccessful Implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)\n\nMicra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.50', 'spread': '11.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethinic Chinese', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '3.89', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-11', 'size': 605701, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-13T23:46', 'hasProtocol': False}, {'date': '2018-04-19', 'size': 4909616, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-14T23:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2018-07-13', 'resultsFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-09', 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Major Complications Free Survival Probability', 'timeFrame': '6 months post implant', 'description': 'Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant'}], 'secondaryOutcomes': [{'measure': 'Pacing Capture Threshold (PCT)', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'Pacing capture threshold @0.24ms pulse width Capture threshold is defined as the minimum electrical stimulus required to consistently capture the heart outside of the myocardial refractory period.\n\nPulse width is the duration of the current flow expressed in milliseconds. The pulse width must be long enough for depolarization to disperse to the surrounding tissue.'}, {'measure': 'Impedance', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'Impedance measured from the Micra device Impedance is the opposition to current flow.'}, {'measure': 'Sensing Amplitude', 'timeFrame': 'Implant, Discharge, Month 1, Month 3, Month 6', 'description': 'R-wave sensing amplitude measured from the Micra device Sensing is the ability of the pacemaker to "see" when a natural (intrinsic) depolarization is occurring.'}, {'measure': 'Adverse Device Effect', 'timeFrame': 'From implant attempt to last subject follow-up, ranging from 0 to 14 months', 'description': 'Adverse event related to the Micra system or implant procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcatheter Pacing System', 'Micra Implantable Device', 'Transfermoral Catheter Delivery System'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for regulatory approval in China.', 'detailedDescription': 'All study sites will be in China. Subjects successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. The overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and China guideline.\n2. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.\n3. Subjects who are at least 18 years of age.\n\nExclusion Criteria:\n\n1. Subject has an existing or prior pacemaker, ICD or CRT device implant.\n2. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.\n3. Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.\n4. Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).\n5. Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.\n6. Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.\n7. Subjects who are considered as unable to tolerate an urgent sternotomy.\n8. Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.\n9. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.\n10. Subjects with a life expectancy of less than 12-months.\n11. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.\n12. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.\n13. Subjects with exclusion criteria required by local law (age or other).\n14. Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT03624504', 'briefTitle': 'China Micra Transcatheter Pacing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'China Micra Transcatheter Pacing Study', 'orgStudyIdInfo': {'id': 'China Micra'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micra Implant Group', 'description': 'Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS)', 'interventionNames': ['Device: Micra Transcatheter Pacing System (TPS)']}], 'interventions': [{'name': 'Micra Transcatheter Pacing System (TPS)', 'type': 'DEVICE', 'description': 'Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements', 'armGroupLabels': ['Micra Implant Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200005', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Shu Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}