Study ID: Amulet Amplatzer
Amplatzer™ Amulet™ left atrial appendage occluder randomized controlled trial
This trial is studying the safety and effectiveness of the Amplatzer Amulet™ device, a left atrial appendage (LAA) occluder that is implanted in patients with non-valvular atrial fibrillation, a type of heart arrhythmia.
There are two study arms to this trial. One group of participants will be implanted with the Amulet, and the other group will be implanted with the Watchman®, another type of LAA occluder. Participants will be followed for five years after device implant.
The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the Amulet™ LAA occluder. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device (treatment) or a Boston Scientific WATCHMAN® LAA closure device (control).
The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit. See the full list of inclusion and exclusion criteria on the clinicaltrials.gov website.
- Must have been diagnosed with non-valvular atrial fibrillation
- Must be willing to have an LAA occluder implanted
- Must be willing to undergo five years of follow-up care and evaluation after device implantation