CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed… (NCT07742839) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
168 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants who have device technical success
Timeframe: Intra-operative
2
Participant's rate of major clinically significant adverse events