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NCT Number: NCT07742839

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 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.

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Key information

Conditions

Atrial Appendage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Device

Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Percentage of participants who have device technical success

    Time frame: 90 days

    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.

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

    Time frame: 90 days, 1, 2, and 3 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Hendrickson

CONTACT

[email protected]

1-949-250-2500

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Clip for LAA closuRe: Evaluating the Safety and Effectiveness of the ECLIPTIS Exclusion sYstem (CLAARITY Study)

Acronym: CLAARITY

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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