Atrial Appendage
Conditions
Brief summary
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.
Detailed description
Subjects in the CLAARITY study will be enrolled at up to 15 sites in the United States. The population will be subjects who will be implanted with the ECLIPTIS clip who are eligible for LAA exclusion when undergoing concomitant open-heart cardiac surgical procedure according to its labeled Instructions for Use (IFU).
Interventions
DEVICEEdwards ECLIPTIS Left Atrial Appendage Exclusion System
Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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
Exclusion criteria
* Known life expectancy \<1 year * Previous cardiac surgery (re-operation) * Prior LAA isolation attempts * Planned right thoracotomy approach * Concomitant open-heart surgery that is considered an emergency * Thrombus in left atrium/LAA that cannot be evacuated before placement of clip * Based on intraoperative evaluation, LAA is not appropriate for exclusion prior to positioning ECLIPTIS clip to the base of the LAA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who have device technical success | Intra-operative | 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 | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who have device technical success | 90 days | 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 | 90 days, 1, 2, and 3 years | 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 |
Contacts
CONTACTKelly Hendrickson
PRINCIPAL_INVESTIGATORChris Malaisrie, MD
Northwestern University
Outcome results
None listed