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The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evera Implanted Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evera MRI ICD System | Device | Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements |
|
| 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 |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China | ||
| Zhongshan Hospital |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pre-MRI scan, immediately post MRI scan, 1-week and 1-month post MRI scan. |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Hua Xi Hospital (West China Hospital) | Chengdu | Sichuan | 610041 | China |