[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650102":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":10},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Edwards ECLIPTIS Left Atrial Appendage Exclusion System",null,"Subjects who were treated with the ECLIPTIS Left Atrial Appendage Exclusion System",[13],"Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System",[9],[20],{"name":21,"affiliation":22,"role":23},"Chris Malaisrie, MD","Northwestern University","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Kelly Hendrickson","CONTACT","1-949-250-2500","Kelly_Hendrickson@edwards.com",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100650102","claarity-is-a-prospective-observational-single-arm-multi-center-post-market-us-study-designed-to-evaluate-the-safety-and-performance-of-the-ecliptis-left-atrial-appendage-exclusion-system-for-exclusion-of-the-left-atrial-appendage-laa-during-concomitant-open-heart-cardiac-surgery-100650102",false,"NCT07742839","CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.","Clip for LAA closuRe: Evaluating the Safety and Effectiveness of the ECLIPTIS Exclusion sYstem (CLAARITY Study)","CLAARITY","Inclusion Criteria:\n\n* ≥18 years old\n* Willing and able to provide consent and comply with study follow-up requirements\n* Scheduled to undergo concomitant open-heart cardiac surgery with planned implantation of ECLIPTIS clip for LAA exclusion per IFU\n\nExclusion Criteria:\n\n* Known life expectancy \\\u003C1 year\n* Previous cardiac surgery (re-operation)\n* Prior LAA isolation attempts\n* Planned right thoracotomy approach\n* Concomitant open-heart surgery that is considered an emergency\n* Thrombus in left atrium\u002FLAA that cannot be evacuated before placement of clip\n* Based on intraoperative evaluation, LAA is not appropriate for exclusion prior to positioning ECLIPTIS clip to the base of the LAA","ALL","18 Years",{"count":43,"type":44},168,"ESTIMATED","OBSERVATIONAL","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.",[48],"Atrial Appendage","NOT_YET_RECRUITING","2026-07-29",{"date":52,"type":53},"2026-08-03","ACTUAL",{"date":55,"type":44},"2026-09-30",{"date":57,"type":44},"2030-08-29",{"name":5,"class":6}]