Stroke Feasibility Study (NCT01997905) | Clinical Trial Compass
CompletedPhase 1/2
Stroke Feasibility Study
United States13 participantsStarted 2014-01
Plain-language summary
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
Who can participate
Age range
18 Years – 80 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
. Patient is ≥ 18 years and ≤ 80 years of age.
. Patient has electrocardiographically confirmed non-valvular atrial fibrillation (paroxysmal, persistent, or longstanding persistent AF).
. CHADS2 or CHA2DS2VASc score ≥2.
. Patient has medical contraindication to long term anticoagulant therapy (OAC), defined as one or more of the following:
. Patient is considered an acceptable surgical candidate, including use of general anesthesia.
. Female patients must be of non-child bearing potential, or have a negative pregnancy test within 7 days prior to index procedure.
Exclusion criteria
. Stroke within 30 days, or TIA within 3 days, respectively, prior to index procedure.
. Documented medical history of any penetrating trauma to thorax, or blunt trauma to thorax which resulted in a left pneumothorax or left hemothorax.
. Myocardial infarction within 60 days prior to index procedure.
. NYHA Class IV heart failure.
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
Number of Serious Adverse Events Within 30 Days Post-Index Procedure
Timeframe: 30 days post-index procedure
2
Composite Left Atrial Appendage Placement and Exclusion Success
Timeframe: Immediate to 3-months post-index procedure
. Prior attempted obliteration of left atrial appendage (percutaneous or open cardiac surgery).
. Previous catheter ablation with perforation or complication.
. Prior open cardiac surgery, or percutaneous coronary intervention with associated unintended cardiac perforation, or pericardial adhesions are suspected.