Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,088 people who received an implanted device called the Amulet, which is designed to close off a small pouch in the heart (the left atrial appendage) to help reduce the risk of blood clots in people with an irregular heartbeat. The trial tracked participants over two years and measured a range of outcomes related to serious medical events, procedure success, and major bleeding. Of the 1,088 who started, 864 completed the study, and 224 did not complete it (the reasons were not broken down in the reported data). The reported data shows that, out of 1,088 participants, 83 people experienced a serious adverse event (an unexpected harmful medical occurrence) within the first 7 days after the procedure, while 504 people experienced a serious adverse event more than 7 days after the procedure. Over the two-year follow-up period, 122 participants experienced either a stroke caused by a blood clot, a blood clot travelling to another part of the body, or death related to the heart or blood vessels. Additionally, 110 participants had a major bleeding event, defined using a standard medical scoring scale for serious bleeding. The reported data also shows that the procedure was recorded as technically successful — meaning the device was placed in the intended location in the heart — in 1,078 out of 1,088 participants. Procedural success, which also required that the participant was discharged from hospital the following day without an adverse event, was recorded for 1,039 participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34381870) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Stroke Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have a history of a type of irregular heartbeat called atrial fibrillation (AF) that comes and goes, is ongoing, or is permanent
- You are 18 years of age or older (or the legal age of adulthood in your region)
- Your doctor has determined that you are a suitable candidate for the Amulet LAA Occluder device based on current medical guidelines
- You are willing and able to give your consent to participate and take part in all parts of the study
Who may not be able to join:
- You have a blood clot inside your heart
- You currently have an active infection, heart valve infection (endocarditis), or a blood infection
- Placing the device in your heart would get in the way of other structures inside your heart or blood vessels
- You have a medical condition that could interfere with completing the study or make it hard to measure the results
- You are a woman who could become pregnant and are currently pregnant, or plan to become pregnant during the study
- The shape or size of the relevant part of your heart (the left atrial appendage) is not suitable for any of the available device sizes (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: David Hildick-Smith, MD, Brighton and Sussex University Hospitals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Acute Serious Adverse Events; Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure; Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death; Number of Participants With Major Bleeding Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.