Trials / Completed

CompletedNCT05324371

WATCHMAN FLX™ CT Study

A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 25 (actual)

Sponsor: Boston Scientific Corporation · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.

Conditions

The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Watchman FLX Device	Left atrial appendage closure using the Watchman FLX device

Timeline

Start date: 2022-11-09
Primary completion: 2024-05-30
Completion: 2025-01-23
First posted: 2022-04-12
Last updated: 2025-07-01
Results posted: 2025-07-01

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05324371. Inclusion in this directory is not an endorsement.