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.

N/ANot Yet RecruitingNCT07742839

Edwards Lifesciences168 enrolled

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.

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

168

Conditions

Atrial Appendage

Interventions

Edwards ECLIPTIS Left Atrial Appendage Exclusion SystemDEVICE

Surgical placement of the Edwards ECLIPTIS Left Atrial Appendage Exclusion System

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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

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