Left Atrial Appendage Exclusion Study (NCT01983605) | Clinical Trial Compass
CompletedNot Applicable
Left Atrial Appendage Exclusion Study
Poland96 participantsStarted 2009-12
Plain-language summary
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
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
. Subject is greater than or equal to 18 years of age
. Subject has atrial fibrillation (paroxysmal or persistent)
. Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)
. Subject is willing and able to provide written informed consent
. Subject has a life expectancy of at least 1 year
. Subject is willing and able to return for scheduled follow up visits
Exclusion criteria
. Previous cardiac surgery
. Thrombus in the left atrial appendage or left atrium
. NYHA Class IV heart failure symptoms
. Need for emergent cardiac surgery (i.e. cardiogenic shock)
. LAA is not appropriate for exclusion based upon intraoperative evaluations
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
1
Rate of device related serious adverse events
Timeframe: 30 days
2
Percent of patients with complete exclusion of the LAA measured with TEE