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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Edwards ECLIPTIS Left Atrial Appendage Exclusion System.
- Who it may be relevant to
- Registry conditions: Atrial Appendage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clip for LAA closuRe: Evaluating the Safety and Effectiveness of the ECLIPTIS Exclusion sYstem (CLAARITY Study)
Overview
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).
Interventions
- Device Edwards ECLIPTIS Left Atrial Appendage Exclusion System
Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System
Primary outcome measures
- Percentage of participants who have device technical success [Time frame: Intra-operative]
- Participant's rate of major clinically significant adverse events [Time frame: 30 days]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07742839 · 2025-09