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

Left Atrial Appendage Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136417
• Other study ID #: 21-009613
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patients is eligible to undergo WATCHMAN device implant procedure.

• The patient is eligible for short term anticoagulation therapy.

• Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).

• Ability to give informed consent for the procedure.

• The patient is able and willing to undergo the procedure under moderate sedation.

• The patient is able and willing to return for required 45-day TEE.

Exclusion Criteria:

• Patient has contraindication for short term anticoagulation.

• The patient has history of a hypercoagulable state per medical record documentation.

• Pregnancy or planning to get pregnant during the investigation.

Related Conditions & MeSH terms

• Left Atrial Appendage Occlusion

Intervention

Device:
• intra-procedural intracardiac echocardiography (ICE) probe
placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Pacific Heart Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful implantation of WATCHMAN FLX device	Number of successfully implanted WACHMAN FLX devices. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant.	45 days post procedure
Primary	Major complications	Number of major complications as defined as major bleeding (intracranial bleeding, or bleeding requiring blood transfusion), pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death).	45 days post procedure

External Links

•   Mayo Clinic Clinical Trials