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. (CLAARITY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Appendage
• Intervention / Treatment: Device: Edwards ECLIPTIS Left Atrial Appendage Exclusion System

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 Type: Observational
• Enrollment (Estimated): 168

Contacts and Locations

• Study Contact: Name: Kelly Hendrickson; Phone Number: 1-949-250-2500; Email: Kelly_Hendrickson@edwards.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	90 days, 1, 2, and 3 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Chris Malaisrie, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): August 29, 2030

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes