Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System (NCT00962702) | Clinical Trial Compass
UnknownPhase 2
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
United States60 participantsStarted 2009-08
Plain-language summary
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
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
. Greater than or equal to 18 years of age
. Stroke Risk (CHADS score \> or = 2, CHADS scoring: CHF = 1 pt, Hypertension (or treated hypertension) = 1 pt, Age \> 75 = 1 pt, Diabetes = 1 pt, Prior stroke or TIA = 2 pts)
. Subject scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following:
. Ejection fraction \> 30%
. Absence of thrombus in LAA
. During open procedure, LAA anatomy is determined to be suitable for closure
. life expectancy of \> 1 year
. patient willingness to cooperate with follow-up tests
Exclusion criteria
. Previous cardiac surgery
. Contraindication to Transesophageal Echocardiography (TEE)
. Thrombus in the LAA/LA
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
The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Timeframe: Patients will be evaluated at 30 days post surgery and at 90 days post surgery.