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

Not Applicable

Completed

• Conditions: Left Atrial Appendage Occlusion
• Interventions: Device: intra-procedural intracardiac echocardiography (ICE) probe

• Registration Number: NCT05136417
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-11-29
• Study Start: 2022-01-04
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-12
• Results First Submitted: 2024-12-03
• Results First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 transesophageal echocardiogram (TEE).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)	intra-procedural intracardiac echocardiography (ICE) probe	100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation.

Primary Outcome Measures

Name	Time	Method
Successful Implantation of WATCHMAN FLX Device	45 days post procedure	Number of participants with a successfully implanted WATCHMAN FLX device. 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 transesophageal echocardiogram (TEE) 45 days post-implant.
Major Complications	up to 7 days post procedure	Number of participants who experience major complications 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).

Secondary Outcome Measures

Name	Time	Method
Procedure Conversion to General Anesthesia	baseline	Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.
Iatrogenic Atrial Septal Defect	45 days post procedure	Number of participants with an iatrogenic atrial septal defect.

Trial Locations

Locations (2)

Pacific Heart Institute; 🇺🇸 Santa Monica, California, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States