An observational study in Non-Valvular Atrial Fibrillation, sponsored by Abbott Medical Devices. Terminated at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Abbott Medical Devices · Observational
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.
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.
Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amulet Left Atrial Appendage Occluder.
Device: Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
Subject will receive the Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder.
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Descriptive Endpoint: Composite of Damage to Blood Vessel or Organ or Damage to Adjacent Organs at Implant, Device Dislodgement, Device Fracture, Device Erosion, or Pericardial Tamponade
Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure. The protocol-defined time frame for endpoint assessment was 5 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.
Time frame: 5 years
Descriptive Endpoint: Rate of Device Success
Rate of device success - defined as device deployed and implanted in correct position
Time frame: During implant procedure, approximately 30 to 60 minutes
Descriptive Endpoint: Rate of Device Closure
Rate of device closure - defined as residual jet around the device of ≤ 5mm, based on the 3-month transesophageal echocardiogram (TEE) defined by Doppler flow
Time frame: 3 months
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Descriptive Endpoint: Percentage of subjects taking OAC or antiplatelet drugs through 5 years. The protocol-defined time frame for endpoint assessment was 5 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.
Time frame: 5 years
A total of 50 subjects were enrolled across five investigational sites in China between January 30, 2024, and January 10, 2025.
| Milestone | Amulet Left Atrial Appendage Occluder |
|---|---|
| Started | 50 |
| Completed | 0 |
| Not completed | 50 |
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.
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events | 0 |
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.
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| 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 | 5 |
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.
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism | 0 |
Composite of damage to blood vessel or organ or damage to adjacent organs at implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 years post-procedure. The protocol-defined time frame for endpoint assessment was 5 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.
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Descriptive Endpoint: Composite of Damage to Blood Vessel or Organ or Damage to Adjacent Organs at Implant, Device Dislodgement, Device Fracture, Device Erosion, or Pericardial Tamponade | 0 |
Rate of device success - defined as device deployed and implanted in correct position
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Descriptive Endpoint: Rate of Device Success | 47 |
Rate of device closure - defined as residual jet around the device of ≤ 5mm, based on the 3-month transesophageal echocardiogram (TEE) defined by Doppler flow
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Descriptive Endpoint: Rate of Device Closure | 20 |
Descriptive Endpoint: Percentage of subjects taking OAC or antiplatelet drugs through 5 years. The protocol-defined time frame for endpoint assessment was 5 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.
| Participants | Amulet Left Atrial Appendage Occluder |
|---|---|
| Pre-Procedure — Oral anticoagulant | 42 |
| Pre-Procedure — Single antiplatelet | 3 |
| Pre-Procedure — Dual antiplatelet | 2 |
| Pre-Procedure — No antithrombotic medication | 2 |
| Discharge — Oral anticoagulant | 43 |
| Discharge — Single antiplatelet | 3 |
| Discharge — Dual antiplatelet | 3 |
| Discharge — No antithrombotic medication | 0 |
| 3 months — Oral anticoagulant | 37 |
| 3 months — Single antiplatelet | 6 |
| 3 months — Dual antiplatelet | 3 |
| 3 months — No antithrombotic medication | 0 |
| 6 months — Oral anticoagulant | 22 |
| 6 months — Single antiplatelet | 14 |
| 6 months — Dual antiplatelet | 10 |
| 6 months — No antithrombotic medication | 0 |
| 12 months — Oral anticoagulant | 13 |
| 12 months — Single antiplatelet | 14 |
| 12 months — Dual antiplatelet | 4 |
| 12 months — No antithrombotic medication | 0 |
Collected over from enrollment until end of follow-up, up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amulet Left Atrial Appendage Occluder | 1/50 (2%) | 10/50 (20%) | 8/50 (16%) |
| Event | Amulet Left Atrial Appendage Occluder |
|---|---|
| Atrial FibrillationCardiac disorders | 2/50 |
| Congestive Heart FailureCardiac disorders | 2/50 |
| PericarditisCardiac disorders | 1/50 |
| Gastrointestinal BleedingGastrointestinal disorders | 1/50 |
| Incarcerated Inguinal HerniaGastrointestinal disorders | 1/50 |
| False AneurysmInjury, poisoning and procedural complications | 1/50 |
| Intracerebral HaemorrhageNervous system disorders | 1/50 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 1/50 |
| EmphysemaRespiratory, thoracic and mediastinal disorders | 1/50 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/50 |
| Event | Amulet Left Atrial Appendage Occluder |
|---|---|
| Pericardial EffusionCardiac disorders | 2/50 |
| Vascular Access Site BruisingInjury, poisoning and procedural complications | 2/50 |
| ThrombusVascular disorders | 2/50 |
| Vascular Access Site PainInjury, poisoning and procedural complications | 1/50 |
| Laboratory Test AbnormalInvestigations | 1/50 |
| Arteriovenous FistulaVascular disorders | 1/50 |
| Peripheral Vein Thrombus ExtensionVascular disorders | 1/50 |
| Age, Continuous(Year) | Amulet Left Atrial Appendage Occluder |
|---|---|
| Mean | 68.7 ± 9.5 |
| Sex: Female, Male(Participants) | Amulet Left Atrial Appendage Occluder |
|---|---|
| Female | 18 |
| Male | 32 |
| Race (NIH/OMB)(Participants) | Amulet Left Atrial Appendage Occluder |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 50 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant(Participants) | Amulet Left Atrial Appendage Occluder |
|---|---|
| High bleeding risk | 42 |
| Prior stroke on anticoagulant | 5 |
| History of major or minor bleeding | 2 |
| Subject's preference/lifestyle | 1 |
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