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The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micra TPS group |
| ||
| Traditional PM group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pacemaker | Device | Micra TPS or traditional PM group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life measured by EQ-5D-5L | The EQ-5D-5L results shall be collected during study follow up visits | 6 Months post implant |
| Health-related quality of life measured by NHP (Nottingham Health Profile) | The NHP results shall be collected during study follow up visits | 6 Months post implant |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are eligible if they meet the indication of a single or dual chamber permanent pacemaker. All subjects should fit the following inclusion criteria and disagree with the exclusion criteria.
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