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The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JX- XFINE lead | Device | Pacemaker subjects implanted with one JX - XFINE passive pacing lead |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant. | 3 months | |
| Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subject indicated for a de novo implantation of a dual chamber (DR) pacemaker as per Guidelines on cardiac pacing and cardiac resynchronization therapy.
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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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| D013568 |
| Pathological Conditions, Signs and Symptoms |