Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Left Atrial Appendage Occlusion
- Sponsor
- Mayo Clinic
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Successful Implantation of WATCHMAN FLX Device
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mohamad Adnan Alkhouli
Principal Investigator
Mayo Clinic
Eligibility Criteria
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).
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.
Outcomes
Primary Outcomes
Successful Implantation of WATCHMAN FLX Device
Time Frame: 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
Time Frame: 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 Outcomes
- Procedure Conversion to General Anesthesia(baseline)
- Iatrogenic Atrial Septal Defect(45 days post procedure)