China Micra Transcatheter Pacing Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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China Micra Transcatheter Pacing Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Micra Transcatheter Pacing System (TPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Subjects who are at least 18 years of age. Exclusion Criteria: Subject has an existing or prior pacemaker, ICD or CRT device implant. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment. 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. Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD). Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head. 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. Subjects who are considered as unable to tolerate an urgent sternotomy. Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated. Subjects with a life expectancy of less than 12-months. 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. 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. Subjects with exclusion criteria required by local law (age or other). Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micra Implant Group<br>Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) | Device: Micra Transcatheter Pacing System (TPS)<br>* Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Pacing System, Micra Implantable Device, Transfermoral Catheter Delivery System