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.

NCT07742839 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-09
• Study Type: observational
• Target: 168
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Appendage

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  30 days

Secondary Outcomes (2)

• Percentage of participants who have device technical success

  90 days

• Participant's rate of major clinically significant adverse events over time

  90 days, 1, 2, and 3 years

Study Arms (1)

Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Subjects who were treated with the ECLIPTIS Left Atrial Appendage Exclusion System

Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Interventions

Edwards ECLIPTIS Left Atrial Appendage Exclusion System DEVICE

Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≥18 years old
• Willing and able to provide consent and comply with study follow-up requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Officials

• Chris Malaisrie, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Hendrickson

CONTACT

1-949-250-2500; Kelly_Hendrickson@edwards.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): August 29, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share