Non-Valvular Atrial FibrillationNCT06189365
Amplatzer Amulet China Post Market Study (PMS)
An observational study of Non-Valvular Atrial Fibrillation, run by Abbott Medical Devices at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation
- What is being tested?
- Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jan 2024to 5 Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This clinical investigation will enroll subjects of all genders from the Chinese nationality general population ≥18 years old. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Who may be able to join
- 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
Who cannot join
- With the presence of intracardiac thrombus
- With active endocarditis or other infections producing bacteremia
- Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score < 3)
- Where placement of the device would interfere with any intracardiac or intravascular structures
- Has a life expectancy of less than 2 years due to any condition
- Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518009
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Xianyang Hospital Of Yan'an University
Xianyang, Shaanxi
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, 412007
About this study
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.
Read the detailed description
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA.
Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC.
The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020.
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.
- Conditions
- Non-Valvular Atrial Fibrillation
- Being tested
- Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
- Keywords
- Non-Valvular Atrial Fibrillation, NVAF, Amplatzer Amulet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluderDevice
Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder.
| Study group | Role | What they receive |
|---|---|---|
| Amulet Left Atrial Appendage Occluder | Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amulet Left Atrial Appendage Occluder. Receives: Device: Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events
The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism.
Measured: 7 days
Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy
The primary long-term safety endpoint is the 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 through 2 years.
The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.
Measured: 2 years
Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism
The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years.
The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start30 Jan 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Why it stopped: This study was terminated due to the shift in Sponsor's business strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhihui ZHANG, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189365
- Sponsor's protocol ID
- ABT-CIP-10491
- Other IDs
- CRD_1028
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2023
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplatzer Amulet China Post Market Study (PMS)
- ClinicalTrials.gov ID
- NCT06189365
- Acronym / sponsor ID
- ABT-CIP-10491
- Conditions
- Non-Valvular Atrial Fibrillation
- Keywords
- Non-Valvular Atrial Fibrillation, NVAF, Amplatzer Amulet
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated due to the shift in Sponsor's business strategy.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA.
Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC.
The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amulet Left Atrial Appendage Occluder | – | Device: Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluderSubject will receive the Left Atrial Appendage (LAA) closure procedure with Amulet Left Atrial Appendage Occluder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll subjects of all genders from the Chinese nationality general population ≥18 years old. Patients must meet all general eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- With the presence of intracardiac thrombus
- With active endocarditis or other infections producing bacteremia
- Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score < 3)
- Where placement of the device would interfere with any intracardiac or intravascular structures
- Has a life expectancy of less than 2 years due to any condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluderSubject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder. | Device | Amulet Left Atrial Appendage Occluder |
Primary outcome
Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events
Time frame: 7 days
The primary short-term safety endpoint is the occurrence of one or more of the following major adverse events within 7 days after the procedure: all-cause mortality, procedure or device-related complications requiring open cardiac surgery or major endovascular intervention, ischemic or hemorrhagic stroke, or systemic embolism.
Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy
Time frame: 2 years
The primary long-term safety endpoint is the 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 through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.
Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism
Time frame: 2 years
The primary effectiveness endpoint is a composite of ischemic stroke or systemic embolism through 2 years. The protocol-defined time frame for endpoint assessment was 2 years. However, the study was prematurely terminated at 1 year and 11 months after study initiation. As a result, the endpoint analysis was conducted using all available data collected up to the point of study termination, but was shorter than the planned observation period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Non-Valvular Atrial Fibrillation
Active, not recruiting
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
Non-valvular Atrial Fibrillation (AF)
Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation
Recruiting
Append Prague Study
Non Valvular Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihui ZHANG principal investigator
The Third Xiangya Hospital of Central South University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Valvular Atrial Fibrillation, run by Abbott Medical Devices at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.