China Evera MRI® Study

Study Overview
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Brief Summary
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The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.

Detailed Description
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The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body). Long-term device effects, such as long-term lead integrity, will not be assessed in the China Evera MRI® study.

Official Title
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China Evera MRI® Study

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Evera MRI ICD System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are indicated for implantation of an ICD at the time of study enrollment. Subjects who are able to undergo a pectoral implant. Subjects who are able and willing to undergo elective MRI scanning without sedation , . Subjects who are geographically stable and available for follow-up at the study site for the length of the study. Subjects who are at least 18 years of age (or older, if required by local law). Exclusion Criteria: Subjects with a history of significant tricuspid valvular disease that precludes the ability to place the RV lead. . Subjects who may be contraindicated to the dexamethasone sodium phosphate and/or dexamethasone acetate. Subjects who require a legally authorized representative to obtain informed consent. Subjects with abandoned or capped leads. Subjects who require an indicated MRI scan, other than those specifically described in the China Evera MRI® study, before the one-month post-MRI follow-up (approximately 4 months post-implant). Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). Subjects with medical conditions that preclude the testing required by the CIP or limit study participation. Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the China Evera MRI® study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant Subjects with exclusion criteria required by local law (e.g., age, breastfeeding). Subjects who are diagnosed with terminal disease with life expectancy less than 4 months.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evera Implanted Group<br> | Device: Evera MRI ICD System<br>* Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of successful MRI scans | To summarize the MRI-related event rate within 30 days post-MRI in patients implanted with an Evera MRI device. | 1 Month Follow up visit after MRI Scan Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of the Evera MRI device post-MRI. | The effectiveness of the Evera MRI device will be measured by the following parameters Atrial pacing capture threshold (only for dual chamber devices) Atrial sensing amplitude (only for dual chamber devices) Ventricular pacing capture threshold Ventricular sensing amplitude These parameters will be measured pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan. | Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan. |