NCT05136417

Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device

Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.

Conditions

• Left Atrial Appendage Occlusion

Interventions

Type	Name	Description
DEVICE	intra-procedural intracardiac echocardiography (ICE) probe	placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.

Timeline

• Start date: 2022-01-04
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2021-11-29
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study