TerminatedNot Applicable

Amplatzer Amulet China Post Market Study (PMS)

Stopped: This study was terminated due to the shift in Sponsor's business strategy.

China50 participantsStarted 2024-01-30

Plain-language summary

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Who can participate

Age range

18 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

. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
. Meets the current device indications and per physician discretion for Amulet implant
. Able to provide written Informed Consent prior to any study related procedures
. 18 years of age or older at the time of enrolment

Exclusion criteria

. With the presence of intracardiac thrombus
. With active endocarditis or other infections producing bacteremia

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

Occurrence of major adverse events

Timeframe: 7 days

Occurrence of device embolization,device erosion,clinically significant device interference with surrounding structure, device thrombus, device fracture, device related infections(endocarditis and pericarditis), device breakage, or device related allergy

Timeframe: 2 years

Composite of ischemic stroke or systemic embolism

Timeframe: 2 years

Trial details

NCT IDNCT06189365

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-05

View on ClinicalTrials.gov More Non-Valvular Atrial Fibrillation trials

Who can participate

Age range

18 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

. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
. Meets the current device indications and per physician discretion for Amulet implant
. Able to provide written Informed Consent prior to any study related procedures
. 18 years of age or older at the time of enrolment

Exclusion criteria

. With the presence of intracardiac thrombus
. With active endocarditis or other infections producing bacteremia

What they're measuring

Occurrence of major adverse events

Timeframe: 7 days

Timeframe: 2 years

Composite of ischemic stroke or systemic embolism

Timeframe: 2 years