CompletedPhase 4

AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

United States562 participantsStarted 2016-02

Plain-language summary

Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patients satisfying the following criteria will be considered the screening population and will be eligible for participation: * Age \> 18 years male or female. * Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where direct access to the LAA is expected. * No documented preoperative AF. * CHA2DS2-VASc score of =\> 2. * HASBLED score of =\> 2. * Acceptable surgical candidate, including use of general anesthesia. * Willing and able to provide written informed consent. Exclusion Criteria: Patients satisfying the following criteria will not be eligible for participation: * Redo cardiac surgery. * Mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period. * Hypercoagulability conditions that may confound the study. * Ejection Fraction \< 30. * Left Atrium \> 6 cm. * Severe Diastolic Dysfunction. * Requires anticoagulation therapy. * Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to signing informed consent. Intra-Operative Exclusion Criteria * Presence of thrombus in the left atrium or LAA. * LAA tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the LAA making AtriClip placement overly risky. * Left atrial appendage is outside the range of manufacturer's recommendations - width \< 29mm or \> 50mm. * Direct visualization access is not available for AtriClip placement.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Perioperative Complications Associated With AtriClip Placement

Timeframe: Within any 24 hour period during the first 2 days post-index procedure

Trial details

NCT IDNCT02701062

SponsorAtriCure, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-26

Results submitted2021-08-26

View on ClinicalTrials.gov More Post-Operative Atrial Fibrillation trials