CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
≥18 years old
Willing and able to provide consent and comply with study follow-up requirements
Scheduled to undergo concomitant open-heart cardiac surgery with planned implantation of ECLIPTIS clip for LAA exclusion per IFU
Known life expectancy <1 year
Previous cardiac surgery (re-operation)
Prior LAA isolation attempts
Planned right thoracotomy approach
The target population includes adult candidates who require exclusion of their left atrial appendage via a surgical clip while undergoing a concomitant cardiac surgical procedure.
Cohort
Prospective
Edwards ECLIPTIS Left Atrial Appendage Exclusion System
DeviceSurgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System
Percentage of participants who have device technical success
Successful ECLIPTIS clip placement and exclusion of LAA, defined as absence of flow (0 mm) between left atrium and LAA, and \<10 mm of residual stump proximal to the clip at the time of the procedure assessed by intra-operative transesophageal echocardiogram (TEE) with Doppler.
Participant's rate of major clinically significant adverse events
Major clinically significant adverse events related to the ECLIPTIS clip and/or ECLIPTIS clip placement procedure within 30 days: * Death * Major bleeding * Major infection * Pericardial effusion requiring intervention * Myocardial infarction requiring intervention * Stroke, systemic embolism
Percentage of participants who have device technical success
Size of any residual flow between the LA and LAA, degree of LAA involution and presence of thrombus at the LAA stump as assessed by CT angiography (CTA) at 90 day follow-up.
Participant's rate of major clinically significant adverse events over time
Major clinically significant adverse events related to the ECLIPTIS clip and/or ECLIPTIS clip placement procedure annually through 3 years * Death * Major bleeding * Major infection * Pericardial effusion requiring intervention * Myocardial infarction requiring intervention * Stroke, systemic embolism
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