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Left Atrial Appendage Occluder
AMPLATZER™ Amulet™ vs WATCHMAN Devices for Stroke Prevention (Amulet IDE Trial)
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) without rheumatic mitral valvular heart disease
Suitable for short term warfarin therapy but unable to take long term oral anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12-months
Awards & highlights
Amulet IDE Trial Summary
This trial will compare the safety and effectiveness of the Amulet device to the WATCHMAN device in people with non-valvular atrial fibrillation.
Who is the study for?
Adults with non-valvular atrial fibrillation who can't take long-term oral anticoagulation but are suitable for short-term warfarin therapy. They must be at high risk of stroke, able to follow post-implant medication regimens, and willing to consent and attend follow-up visits. Exclusions include recent stroke or TIA, severe heart failure, certain allergies, pregnancy, severe renal failure, planned surgeries close to the trial period.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of the Amulet Left Atrial Appendage Occluder compared to the WATCHMAN device in preventing strokes in patients with atrial fibrillation. Participants will be randomly assigned one of these devices and monitored over five years.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from device implantation like bleeding or infection; allergic reactions if sensitive to device materials; blood clots around the device leading to possible stroke; and general risks associated with catheterization procedures.
Amulet IDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a type of irregular heartbeat not caused by a heart valve issue.
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I can take warfarin for a short time but not long-term oral blood thinners.
Select...
I am at high risk for stroke or blood clots.
Select...
I am 18 years old or older.
Amulet IDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)
Embolism
Hemorrhage
Secondary outcome measures
Cardiovascular system
Hemorrhage
Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
+2 moreAmulet IDE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AmuletExperimental Treatment1 Intervention
Amulet left atrial appendage occluder
Group II: WATCHMAN (Control)Active Control1 Intervention
WATCHMAN left atrial appendage closure device
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
402,310 Total Patients Enrolled
15 Trials studying Stroke
15,340 Patients Enrolled for Stroke
Dhanunjaya Lakkireddy, MDStudy ChairUniversity of Kansas
28 Previous Clinical Trials
6,346 Total Patients Enrolled
4 Trials studying Stroke
1,398 Patients Enrolled for Stroke
David Thaler, MD, PhDStudy ChairThe Comprehensive Stroke Center at Tufts Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a temporary episode of atrial fibrillation.My kidney function is severely reduced.I have an active heart infection or a blood infection.I have a type of irregular heartbeat not caused by a heart valve issue.I need a different option than warfarin for blood thinning.I can take warfarin for a short time but not long-term oral blood thinners.I have symptoms from a narrowed artery in my neck.I am prescribed a long-term P2Y12 inhibitor for my condition.I am at high risk for general anesthesia.I have not had any heart or other surgeries in the last 30 days.I cannot take aspirin, clopidogrel, or warfarin due to allergies or other reasons.I can come back for all needed follow-ups.I am at high risk for stroke or blood clots.I need transfusions due to low platelet or red blood cell counts.My heart's pumping ability is significantly reduced.I need long-term blood thinners for a condition that is not atrial fibrillation.I have had blood clots in my veins without a known cause, more than once.I am 18 years old or older.I have not had a heart attack in the last 90 days.I have severe heart failure.I don't have any conditions that would prevent me from having a catheterization procedure.I have had a procedure to close off the left atrial appendage of my heart.My atrial fibrillation can be treated or reversed.I have not had a stroke or TIA in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Amulet
- Group 2: WATCHMAN (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants within this experiment?
"Unfortunately, the data hosted on clinicaltrials.gov suggests that this research has concluded its recruitment process and is no longer enrolling patients. The trial first appeared in August 2016 but was last updated in October 2022. Fortunately, there are still 1044 other trials actively seeking volunteers right now."
Answered by AI
How many medical facilities are hosting this clinical research?
"This study is currently underway across 95 clinical trial sites. Notable locations include New york Presbyterian/Columbia University Medical Center in Manhattan, Lankenau Institute for Medical Research in Wynnewood and St Joseph's Hospital in Saint Paul."
Answered by AI
What is the main goal of this trial?
"This clinical trial is focused on the primary outcome of composite endpoint rate of procedure-related complications, or all-cause death or major bleeding (defined as type 3 or greater based on the Bleeding Academic Research Consortium [BARC] definition). A non-inferiority analysis will be used to measure this at 18 months. Secondary objectives include a superiority test for device closure, rates of major bleeding and assessment of procedure related complications. Furthermore, definite fatal bleedings are also taken into account when assessing efficacy."
Answered by AI
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