MedTrace Logo

Observe the Safety and Effectiveness of the WATCHMAN FLX™ for Subjects in Hong Kong

NCT04096963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-08-12

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to observe the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation to reduce the risk of stroke in Hong Kong area.

Conditions

  • Non-valvular Atrial Fibrillation

Interventions

DEVICE

The WATCHMAN FLX Delivery System

WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Chan Chin Pang Gary · Prince of Wales Hospital

  • Fung Chi Yan Raymond · Princess Margaret Hospital, Canada

  • Tsui Kin Lam · Pamela Youde Nethersole Hospital

  • Simon Lam · Queen Mary Hospital, Hong Kong

  • SF Chui · The Queen Elizabeth Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2022-01-24
Completion
2023-03-28
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096963 on ClinicalTrials.gov