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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micra Implant Group | Experimental | Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micra Transcatheter Pacing System (TPS) | Device | Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Complications Free Survival Probability | Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant | 6 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Pacing Capture Threshold (PCT) | 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. Pulse 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. | Implant, Discharge, Month 1, Month 3, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu Zhang, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100037 | China | ||
| Beijing Anzhen Hospital, Capital Medical University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Micra Implant Group | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Micra Implant Group | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Major Complications Free Survival Probability | Freedom rate from Micra implant procedure and/or system related major complications through 6 months post implant | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months post implant |
|
|
From implant attempt to last subject follow-up, ranging from 0 to 14 months
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micra Implant Group | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Weifan Sun, Clinical Study Manager | Medtronic (Shanghai) Management Co., Ltd. | 021-20325267 | 86 | weifan.sun@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2018 | Jul 13, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 19, 2018 | Jul 14, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Single Group Assignment
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| Impedance | Impedance measured from the Micra device Impedance is the opposition to current flow. | Implant, Discharge, Month 1, Month 3, Month 6 |
| Sensing Amplitude | 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. | Implant, Discharge, Month 1, Month 3, Month 6 |
| Adverse Device Effect | Adverse event related to the Micra system or implant procedure | From implant attempt to last subject follow-up, ranging from 0 to 14 months |
| Beijing |
| Beijing Municipality |
| China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Ruijin Hospital Affliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200005 | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| The Second Affliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Pacing Capture Threshold (PCT) | 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. Pulse 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. | 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. | Posted | Mean | Standard Deviation | Volts | Implant, Discharge, Month 1, Month 3, Month 6 |
|
|
|
| Secondary | Impedance | Impedance measured from the Micra device Impedance is the opposition to current flow. | 81 subject with successful implant | Posted | Mean | Standard Deviation | Ohms | Implant, Discharge, Month 1, Month 3, Month 6 |
|
|
|
| Secondary | Sensing Amplitude | 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. | 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. | Posted | Mean | Standard Deviation | mV | Implant, Discharge, Month 1, Month 3, Month 6 |
|
|
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| Secondary | Adverse Device Effect | Adverse event related to the Micra system or implant procedure | All enrolled patients with an implant attempt | Posted | Count of Participants | Participants | From implant attempt to last subject follow-up, ranging from 0 to 14 months |
|
|
|
| 0 |
| 82 |
| 12 |
| 82 |
| 8 |
| 82 |
| Angina unstable | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cholangitis acute | Hepatobiliary disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hepatic angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Non-systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| 1 Month |
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| 3 Months |
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| 6 Months |
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| Title | Measurements |
|---|---|
|
| 3 Months |
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| 6 Months |
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| 1 Month |
|
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| 3 Months |
|
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| 6 Months |
|
|
| Title | Measurements |
|---|---|
|
| Chest pain |
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| Deep vein thrombosis |
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| Device pacing issue |
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| Dizziness |
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| Myocardial necrosis marker increased |
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| Oedema peripheral |
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| Pyrexia |
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| Thrombocytopenia |
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| Troponin increased |
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| Ventricular extrasystoles |
|