NCT03693092

LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 156 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

Detailed description

All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call. During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-04-01
• Completion: 2020-07-01
• First posted: 2018-10-02
• Last updated: 2018-10-02

Locations

11 sites across 1 country: China