Trial Outcomes & Findings for Amplatzer Amulet China Post Market Study (PMS) (NCT NCT06189365)
NCT ID: NCT06189365
Last Updated: 2026-08-13
Results Overview
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.
TERMINATED
50 participants
7 days
2026-08-13
Participant Flow
A total of 50 subjects were enrolled across five investigational sites in China between January 30, 2024, and January 10, 2025.
Participant milestones
| Measure |
Amulet Left Atrial Appendage Occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amplatzer Amulet China Post Market Study (PMS)
Baseline characteristics by cohort
| Measure |
Amulet Left Atrial Appendage Occluder
n=50 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Age, Continuous
|
68.7 Year
STANDARD_DEVIATION 9.5 • n=1 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant
High bleeding risk
|
42 Participants
n=1 Participants
|
|
Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant
Prior stroke on anticoagulant
|
5 Participants
n=1 Participants
|
|
Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant
History of major or minor bleeding
|
2 Participants
n=1 Participants
|
|
Primary reason for seeking an alternative or unable to take long-term warfarin/other anticoagulant
Subject's preference/lifestyle
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The number of participants analyzed includes subjects with Amulet occluder implanted.
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.
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=47 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The number of participants analyzed includes subjects with Amulet occluder implanted.
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.
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=47 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
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 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The number of participants analyzed includes subjects with Amulet occluder implanted.
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.
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=47 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: The number of participants analyzed includes subjects with Amulet occluder implanted.
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.
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=47 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
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 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During implant procedure, approximately 30 to 60 minutesPopulation: Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.
Rate of device success - defined as device deployed and implanted in correct position
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=50 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Descriptive Endpoint: Rate of Device Success
|
47 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Analysis included subjects who had evaluable leak assessments at 3 months.
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
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=20 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Descriptive Endpoint: Rate of Device Closure
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
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.
Outcome measures
| Measure |
Amulet Left Atrial Appendage Occluder
n=49 Participants
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Pre-Procedure · Oral anticoagulant
|
42 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Pre-Procedure · Single antiplatelet
|
3 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Pre-Procedure · Dual antiplatelet
|
2 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Pre-Procedure · No antithrombotic medication
|
2 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Discharge · Oral anticoagulant
|
43 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Discharge · Single antiplatelet
|
3 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Discharge · Dual antiplatelet
|
3 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
Discharge · No antithrombotic medication
|
0 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
3 months · Oral anticoagulant
|
37 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
3 months · Single antiplatelet
|
6 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
3 months · Dual antiplatelet
|
3 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
3 months · No antithrombotic medication
|
0 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
6 months · Oral anticoagulant
|
22 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
6 months · Single antiplatelet
|
14 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
6 months · Dual antiplatelet
|
10 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
6 months · No antithrombotic medication
|
0 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
12 months · Oral anticoagulant
|
13 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
12 months · Single antiplatelet
|
14 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
12 months · Dual antiplatelet
|
4 Participants
|
|
Descriptive Endpoint: Percentage of Subjects Taking OAC or Antiplatelet Drugs
12 months · No antithrombotic medication
|
0 Participants
|
Adverse Events
Amulet Left Atrial Appendage Occluder
Serious adverse events
| Measure |
Amulet Left Atrial Appendage Occluder
n=50 participants at risk
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
4.0%
2/50 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Congestive Heart Failure
|
4.0%
2/50 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
|
Cardiac disorders
Pericarditis
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Gastrointestinal disorders
Incarcerated Inguinal Hernia
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
False Aneurysm
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Nervous system disorders
Intracerebral Haemorrhage
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
Other adverse events
| Measure |
Amulet Left Atrial Appendage Occluder
n=50 participants at risk
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|
|
Cardiac disorders
Pericardial Effusion
|
4.0%
2/50 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Bruising
|
4.0%
2/50 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Investigations
Laboratory Test Abnormal
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Peripheral Vein Thrombus Extension
|
2.0%
1/50 • Number of events 1 • from enrollment until end of follow-up, up to 12 months
|
|
Vascular disorders
Thrombus
|
4.0%
2/50 • Number of events 2 • from enrollment until end of follow-up, up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place