Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
NCT05793502 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2024-08-26
Summary
This study is aimed to assess the effectiveness and safety of LBBaP with Solia S and Selectra 3D in the Chinese population by analyzing the operation success rate and the system stability during follow-up visits.
Conditions
- Consented to Participate in the Trial and Signed an ICF
- Patients With an Indication for PM Implantation or CRTP
Interventions
- DEVICE
-
Solia S and Selectra 3D Developed by BIOTRONIK
LBBaP with Solia S and Selectra 3D Developed by BIOTRONIK
Sponsors & Collaborators
-
Chinese Academy of Medical Sciences, Fuwai Hospital
lead OTHER
Principal Investigators
-
Chen Keping, Doctor · Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-04
- Primary Completion
- 2025-04-20
- Completion
- 2025-04-20
- FDA Device
- Yes
Countries
- China
Study Locations
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