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.
Study Type
OBSERVATIONAL
Enrollment
246
Micra TPS or traditional PM group
Health-related quality of life measured by EQ-5D-5L
The EQ-5D-5L results shall be collected during study follow up visits
Time frame: 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
Time frame: 6 Months post implant
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