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.

ConditionAtrial Appendage

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorEdwards Lifesciences

About this trial

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.

Eligibility criteria

Qualifiers

≥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

Disqualifiers

Known life expectancy <1 year

Previous cardiac surgery (re-operation)

Prior LAA isolation attempts

Planned right thoracotomy approach

Trial design

Treatments tested in this trial

Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Treatment groups

168 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov