NCT05567172

Watchman FLX Pro CT Pilot Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of cardiac computed tomography (CT) and transesophageal echocardiography (TEE) and assess its relationship, if any, to clinical events.

Detailed description

WATCHMAN FLX™ Pro CT is a prospective, single-arm, single-center, premarket investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX Pro device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used. A core laboratory will independently assess select results. A subject is considered enrolled in the study when the subject or the subject's legally authorized representative signs an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC). Up to 50 subjects in whom placement of a WATCHMAN FLX Pro device is attempted will be enrolled. A baseline assessment including TEE and/or CT imaging with optional cardiac magnetic resonance imaging (MRI) will be done within 7 days prior to the index procedure following core laboratory guidelines. Follow-up clinical assessment and imaging will occur at 14 days, 45 days, and 3 months post index procedure; only clinical assessment will be required at 12 months (unless an in-person assessment is required based on other data). Subjects who are enrolled but not implanted with a WATCHMAN FLX Pro LAAC device will be followed for safety through 12 months after the initial attempted index procedure but will not undergo imaging assessments or evaluation of biochemical markers including measures of coagulation, platelet and endothelial activation and inflammation.

Conditions

• Non-valvular Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DEVICE	Left atrial appendage closure device WM FLX Pro	Left atrial appendage closure

Timeline

• Start date: 2023-03-24
• Primary completion: 2024-10-14
• Completion: 2025-06-18
• First posted: 2022-10-05
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

1 site across 1 country: Denmark