Your session is about to expire
← Back to Search
Left Atrial Appendage Occlusion with AMULET using Steerable Delivery Sheaths for Stroke and Atrial Fibrillation
Study Summary
This trial finds that the Amplatzer steerable delivery sheath is safe and effective for left atrial appendage occlusion, but no better than the traditional fixed curve sheath.
- Stroke
- Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- You have atrial fibrillation and are having a specific heart device implanted.You have a medical device implanted other than the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.
- Group 1: Patients with Amulet device using non-steerable fixed curve sheath
- Group 2: Patients with Amulet device using a novel steerable sheath
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What outcome is this experiment aiming to achieve?
"The primary endpoint of this research, assessed within a day, is Need for Pericardiocentesis. Secondary endpoints include the Number of Device Repositions that were done during the study period, the Quantity of Patients with Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) in 6 months after treatment completion and finally Closure Rates which are monitored over 45 days post Left Atrial Appendage closure (<= 3mm)."
Is this research endeavor presently enrolling participants?
"The records from clinicaltrials.gov indicate that this particular trial is not presently recruiting participants, even though it was initially launched on August 1st 2022 and its data was last modified on July 14th 2022. Fortunately, there are currently 1,471 other studies seeking volunteers for participation."
Share this study with friends
Copy Link
Messenger