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ACTIVE NOT RECRUITING
NCT07385599
NA

FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients

Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

Official title: A First-in-Man (FIM) Study of the LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-01-19

Completion Date

2028-03-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DEVICE

LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System

To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong, HKSAR

Shatin, Hong Kong