Atrial AppendageCLAARITYNCT07742839
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.
An observational study of Atrial Appendage, run by Edwards Lifesciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Appendage
- What is being tested?
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 29 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clip for LAA closuRe: Evaluating the Safety and Effectiveness of the ECLIPTIS Exclusion sYstem (CLAARITY Study)
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.
Read the 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).
- Conditions
- Atrial Appendage
- Being tested
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards ECLIPTIS Left Atrial Appendage Exclusion SystemDevice
Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System
| Study group | Role | What they receive |
|---|---|---|
| Edwards ECLIPTIS Left Atrial Appendage Exclusion System | Subjects who were treated with the ECLIPTIS Left Atrial Appendage Exclusion System Receives: Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operative
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
Measured: 30 days
Secondary outcomes (2)
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.
Measured: 90 days
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
Measured: 90 days, 1, 2, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion29 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial AppendageStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Malaisrie, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742839
- Sponsor's protocol ID
- 2025-09
- Acronym
- CLAARITY
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clip for LAA closuRe: Evaluating the Safety and Effectiveness of the ECLIPTIS Exclusion sYstem (CLAARITY Study)
- ClinicalTrials.gov ID
- NCT07742839
- Acronym / sponsor ID
- CLAARITY / 2025-09
- Conditions
- Atrial Appendage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 29 Aug 2030 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards ECLIPTIS Left Atrial Appendage Exclusion System | – | Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion SystemSubjects who were treated with the ECLIPTIS Left Atrial Appendage Exclusion System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards ECLIPTIS Left Atrial Appendage Exclusion SystemSurgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System | Device | Edwards ECLIPTIS Left Atrial Appendage Exclusion System |
Primary outcome
Percentage of participants who have device technical success
Time frame: 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
Time frame: 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
2 secondary outcomes
Percentage of participants who have device technical success
Time frame: 90 days
Participant's rate of major clinically significant adverse events over time
Time frame: 90 days, 1, 2, and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Malaisrie, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Appendage, run by Edwards Lifesciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Hendrickson (1-949-250-2500, Kelly_Hendrickson@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who have device technical success (time frame: Intra-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.