Trial Outcomes & Findings for AMPLATZER™ Amulet™ LAA Occluder Trial (NCT NCT02879448)
NCT ID: NCT02879448
Last Updated: 2025-02-26
Results Overview
Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of ≥ 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding * Type 5b: Definite fatal bleeding
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1878 participants
Primary outcome timeframe
At 12-months
Results posted on
2025-02-26
Participant Flow
A total of 2079 subjects were enrolled at 115 investigational centers and Amulet IDE trial included 2079 subjects with 1878 Randomized subjects (934 in the Amulet group and 944 in the Watchman group) and 201 roll-in subjects.
Of the 2592 subjects who consented initially, 513 subjects did not enroll in the Amulet IDE trial due to screen failures, withdrawal of consent, and other reasons. Hence, the actual enrollment was 1878 Randomized subjects and 201 roll-in subjects.
Participant milestones
| Measure |
Amulet
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
WATCHMAN (Control)
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Overall Study
STARTED
|
934
|
944
|
|
Overall Study
COMPLETED
|
610
|
562
|
|
Overall Study
NOT COMPLETED
|
324
|
382
|
Reasons for withdrawal
| Measure |
Amulet
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
WATCHMAN (Control)
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Overall Study
Death
|
251
|
263
|
|
Overall Study
Lost to Follow-up
|
23
|
28
|
|
Overall Study
Withdrawal by Subject
|
42
|
79
|
|
Overall Study
Other Reasons
|
8
|
12
|
Baseline Characteristics
AMPLATZER™ Amulet™ LAA Occluder Trial
Baseline characteristics by cohort
| Measure |
Amulet
n=934 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
WATCHMAN (Control)
n=944 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Total
n=1878 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
75.1 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
75.0 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
385 Participants
n=5 Participants
|
365 Participants
n=7 Participants
|
750 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
549 Participants
n=5 Participants
|
579 Participants
n=7 Participants
|
1128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
838 Participants
n=5 Participants
|
851 Participants
n=7 Participants
|
1689 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Declined or Unable to Disclose Due to Local Regulation
|
57 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
26 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
102 participants
n=5 Participants
|
101 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
792 participants
n=5 Participants
|
806 participants
n=7 Participants
|
1598 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
History of major or minor bleeding
|
515 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
1018 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of ≥ 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding * Type 5b: Definite fatal bleeding
Outcome measures
| Measure |
WATCHMAN (Control)
n=896 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=903 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition) (Non-inferiority Analysis)
|
14.7 Percentage of participants
|
14.5 Percentage of participants
|
PRIMARY outcome
Timeframe: At 18-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.
Outcome measures
| Measure |
WATCHMAN (Control)
n=944 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=934 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)
|
2.8 Percentage of participants
|
2.8 Percentage of participants
|
PRIMARY outcome
Timeframe: At 45-daysPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.
Outcome measures
| Measure |
WATCHMAN (Control)
n=792 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=801 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)
|
96.8 Percentage of participants
|
98.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At 18-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion. Cardiovascular/unexplained death includes: * Death due to proximate cardiac cause * Death caused by non-coronary/non-CNS vascular conditions * Death from vascular CNS causes * All procedure-related deaths * Sudden/unwitnessed death * Death of unknown cause
Outcome measures
| Measure |
WATCHMAN (Control)
n=916 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=915 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)
|
7.7 Percentage of participants
|
5.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At 18-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Major bleeding rate defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition was assessed * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of ≥ 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging * Type 5b: Definite fatal bleeding: bleeding that is directly observed or confirmed on autopsy
Outcome measures
| Measure |
WATCHMAN (Control)
n=916 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=917 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Rate of Major Bleeding (Superiority Analysis)
|
12.3 Percentage of participants
|
11.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At 12-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of ≥ 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding * Type 5b: Definite fatal bleeding
Outcome measures
| Measure |
WATCHMAN (Control)
n=896 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=903 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Superiority Test of Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition)
|
14.7 percentage of participants
|
14.5 percentage of participants
|
SECONDARY outcome
Timeframe: At 18-monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.
Outcome measures
| Measure |
WATCHMAN (Control)
n=944 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=934 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
|
2.8 Percentage of participants
|
2.8 Percentage of participants
|
SECONDARY outcome
Timeframe: At 45-daysPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.
Outcome measures
| Measure |
WATCHMAN (Control)
n=792 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=801 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab
|
96.8 Percentage of participants
|
98.9 Percentage of participants
|
POST_HOC outcome
Timeframe: 5 YearsPopulation: Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.
Ischemic Stroke is defined as an acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue and Systemic Embolism is define as Acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.
Outcome measures
| Measure |
WATCHMAN (Control)
n=916 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=917 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Composite Rate of Ischemic Stroke and Systemic Embolism
|
7.1 percentage of participants
|
7.4 percentage of participants
|
POST_HOC outcome
Timeframe: 5 YearsPopulation: Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.
Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion. Cardiovascular/unexplained death includes: Death due to proximate cardiac cause Death caused by non-coronary/non-CNS vascular conditions Death from vascular CNS causes All procedure-related deaths Sudden/unwitnessed death Death of unknown cause
Outcome measures
| Measure |
WATCHMAN (Control)
n=916 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=917 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Composite Rate of Stroke, Systemic Embolism, or CV/Unexplained Death
|
20.7 percentage of participants
|
20.3 percentage of participants
|
POST_HOC outcome
Timeframe: 5 YearsPopulation: Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.
Major bleeding: Type 3a: Any transfusion with overt bleeding. Overt bleeding plus a hemoglobin drop of ≥ 3 to \< 5 g/dL. Type 3b: Overt bleeding plus hemoglobin drop ≥ 5 g/dL. Cardiac tamponade. Bleeding requiring surgical intervention for Watchman (excluding dental/nasal/skin/ hemorrhoid). Bleeding requiring intravenous vasoactive drugs. Type 3c:Intracranial hemorrhage including subdural hemorrhages (does not include microbleeds or hemorrhagic transformation, does include intraspinal). Subcategories confirmed by autopsy or imaging or lumbar puncture. Intraocular bleed compromising vision. Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging. Type 5b: Definite fatal bleeding: bleeding that is directly observed (by either clinical specimen) or confirmed on autopsy.
Outcome measures
| Measure |
WATCHMAN (Control)
n=916 Participants
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
Amulet
n=917 Participants
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Rate of Major Bleeding
|
20.0 percentage of participants
|
20.1 percentage of participants
|
Adverse Events
Amulet
Serious events: 542 serious events
Other events: 293 other events
Deaths: 251 deaths
WATCHMAN (Control)
Serious events: 535 serious events
Other events: 266 other events
Deaths: 263 deaths
Serious adverse events
| Measure |
Amulet
n=934 participants at risk
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
WATCHMAN (Control)
n=944 participants at risk
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemias
|
3.5%
33/934 • 5 years
|
2.6%
25/944 • 5 years
|
|
Blood and lymphatic system disorders
Aplastic Anemia/Hypoplastic Anemia
|
0.21%
2/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Blood and lymphatic system disorders
Iron-Deficiency Anemia
|
0.00%
0/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Cardiac disorders
Aortic Valve Insufficiency/Aortic Valve Regurgitation/Valvular Regurgitation Aortic Valve
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
High Grade Block/Advanced AV Block
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
|
0.21%
2/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
AV Block
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Acute Pulmonary Edema
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Angina Pectoris
|
0.11%
1/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Cardiac disorders
Anterior Myocardial Infarction
|
2.9%
27/934 • 5 years
|
2.3%
22/944 • 5 years
|
|
Cardiac disorders
Aortic Aneurysms
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Aortic Dissection
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.75%
7/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Cardiac disorders
Asystole
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Atrial Flutter
|
0.43%
4/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
3.9%
36/934 • 5 years
|
4.1%
39/944 • 5 years
|
|
Cardiac disorders
Cardiac Perforation
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Cardiac Thrombus
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Cardiogenic Shock
|
0.43%
4/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Chest Pain
|
1.4%
13/934 • 5 years
|
2.1%
20/944 • 5 years
|
|
Cardiac disorders
Congestive Heart Failure
|
12.1%
113/934 • 5 years
|
11.1%
105/944 • 5 years
|
|
Cardiac disorders
Constrictive Pericarditis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Cor Pulmonale
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Coronary Artery Disease
|
1.2%
11/934 • 5 years
|
1.4%
13/944 • 5 years
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Dyspnea
|
0.43%
4/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Cardiac disorders
Inferior Myocardial Infarction
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
0.96%
9/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.8%
17/934 • 5 years
|
0.74%
7/944 • 5 years
|
|
Cardiac disorders
Pericardial Tamponade
|
1.9%
18/934 • 5 years
|
1.5%
14/944 • 5 years
|
|
Cardiac disorders
Pericarditis
|
0.86%
8/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
Perivalvular Leak
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.86%
8/934 • 5 years
|
0.64%
6/944 • 5 years
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.75%
7/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Supravalvular Aortic Stenosis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Sustained Ventricular Tachycardia
|
0.11%
1/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
0.21%
2/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Cardiac disorders
Unstable Angina
|
0.32%
3/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.43%
4/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Eye disorders
Eye Bleed
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.32%
3/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Acute Peritonitis
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Emesis/Vomiting
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
10.5%
98/934 • 5 years
|
10.5%
99/944 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids/Piles
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Hemiparesis/Weakness
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Tingling
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Weakness
|
0.64%
6/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
General disorders
Damage or Movement of ICD Leads Requiring Revisions
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Drug Side Effect
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Failure to Thrive
|
0.75%
7/934 • 5 years
|
0.95%
9/944 • 5 years
|
|
General disorders
Fatigue/Generalized Fatigue
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Fever
|
0.11%
1/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
General disorders
Multiple Organ Failure
|
1.8%
17/934 • 5 years
|
1.7%
16/944 • 5 years
|
|
General disorders
Neck Pain
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Non-Cardiac Chest Pain
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
General disorders
Other
|
2.7%
25/934 • 5 years
|
2.6%
25/944 • 5 years
|
|
Hepatobiliary disorders
Choledocholithiaisis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Hepatobiliary disorders
Choledocholithiasis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Hepatobiliary disorders
Hepatic and Biliary Disorders
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Infections and infestations
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Bacterial Infections of the Skin
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Subacute Bacterial Endocarditis (SBE)
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Acute Bacterial Endocarditis (ABE)
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Bacteremia
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Bacterial Infections
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Chlamydial Pneumonia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Influenza
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Pneumonia
|
2.4%
22/934 • 5 years
|
2.5%
24/944 • 5 years
|
|
Infections and infestations
Respiratory Syncytial Virus Infection (RSV)
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Sepsis
|
2.4%
22/934 • 5 years
|
1.9%
18/944 • 5 years
|
|
Infections and infestations
Septicemia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Urinary Tract Infections
|
0.64%
6/934 • 5 years
|
0.74%
7/944 • 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Air Embolus
|
0.21%
2/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Injury, poisoning and procedural complications
Closed Head Injury
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
Epidural Hematomas
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Esophageal Laceration and Rupture
|
0.11%
1/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
7/934 • 5 years
|
1.4%
13/944 • 5 years
|
|
Injury, poisoning and procedural complications
Hemothorax
|
0.43%
4/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
Trauma
|
3.1%
29/934 • 5 years
|
3.1%
29/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Bleeding
|
0.11%
1/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Hematoma
|
0.32%
3/934 • 5 years
|
0.85%
8/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Pseudoaneurysm
|
0.11%
1/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Vessel Perforation
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Investigations
Abnormal Coagulation Parameter
|
0.00%
0/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Investigations
Abnormal Lab Value
|
0.21%
2/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Investigations
EKG Abnormalities
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Investigations
Echo Finding
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Poor Nutrition
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Edema
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Hypervolemia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
3.0%
28/934 • 5 years
|
3.0%
28/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemias
|
0.54%
5/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.21%
2/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Cancer
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Cerebral Edema
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Dysarthria/Slurred Speech
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Facial Paresis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Intracerebral Haemorrhage
|
0.96%
9/934 • 5 years
|
0.64%
6/944 • 5 years
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Ischemic Stroke
|
6.1%
57/934 • 5 years
|
5.6%
53/944 • 5 years
|
|
Nervous system disorders
Stroke
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Unmasking Old Stroke Symptoms
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Visual Disturbance
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Acute Subdural Hematoma
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Altered Sensorium
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Bells Palsy
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Blurred Vision
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Cerebral Aneurysm
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Concussion
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Delirium
|
0.21%
2/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Nervous system disorders
Dementia
|
0.54%
5/934 • 5 years
|
0.95%
9/944 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.64%
6/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
2.4%
22/934 • 5 years
|
2.5%
24/944 • 5 years
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Microhemorrhage
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Migraine
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Neuralgic Facial Pain
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
New and Different Onset of Migraine Symptoms
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Numbness
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Parkinson's Disease
|
0.43%
4/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Radiculopathy
|
0.11%
1/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Seizure Disorder
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
0.64%
6/934 • 5 years
|
1.2%
11/944 • 5 years
|
|
Nervous system disorders
Spells
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Subarachnoid Hemorrhage
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Subdural Haemorrhage
|
0.21%
2/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Nervous system disorders
Transient Global Amnesia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
1.7%
16/934 • 5 years
|
2.0%
19/944 • 5 years
|
|
Nervous system disorders
Vertigo
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Product Issues
Device Embolization
|
0.64%
6/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Product Issues
Device Malposition or Malfunction
|
0.11%
1/934 • 5 years
|
0.85%
8/944 • 5 years
|
|
Product Issues
Thrombus on Device
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Psychiatric disorders
Suicide
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Psychiatric disorders
Suicide Attempt
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Renal and urinary disorders
Kidney Cyst
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Phimosis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Renal and urinary disorders
Renal Failure
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.96%
9/934 • 5 years
|
0.74%
7/944 • 5 years
|
|
Renal and urinary disorders
Chronic Renal Failure
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
1.8%
17/934 • 5 years
|
1.3%
12/944 • 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Renal Infarct
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Renal and urinary disorders
Urinary Calculi
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.11%
1/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.54%
5/934 • 5 years
|
0.95%
9/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.96%
9/934 • 5 years
|
1.1%
10/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
16/934 • 5 years
|
2.1%
20/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
15/934 • 5 years
|
3.0%
28/944 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Surgical and medical procedures
Residual Shunt Requiring Closure
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Surgical and medical procedures
Surgical Closure of ASD
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Claudication
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Hemorrhage
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Seroma
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Vascular Ischemia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Abdominal Bleeding
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
0.21%
2/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Vascular disorders
Bleeding
|
1.1%
10/934 • 5 years
|
1.6%
15/944 • 5 years
|
|
Vascular disorders
Blood Loss
|
0.21%
2/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Vascular disorders
Carotid Stenosis
|
0.43%
4/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Deep Vein/Venous Thrombosis
|
0.75%
7/934 • 5 years
|
0.74%
7/944 • 5 years
|
|
Vascular disorders
Epistaxis
|
1.4%
13/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Vascular disorders
Hematoma
|
0.86%
8/934 • 5 years
|
1.4%
13/944 • 5 years
|
|
Vascular disorders
Hemoptysis
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Vascular disorders
Hypotension
|
0.86%
8/934 • 5 years
|
0.74%
7/944 • 5 years
|
|
Vascular disorders
Orthostatic Hypotension
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Peripheral Arterial Occlusion
|
0.43%
4/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.86%
8/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Vascular disorders
Peripheral Venous Thrombus
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Syncope
|
1.7%
16/934 • 5 years
|
1.8%
17/944 • 5 years
|
|
Vascular disorders
Systemic Embolism
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
Other adverse events
| Measure |
Amulet
n=934 participants at risk
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure
|
WATCHMAN (Control)
n=944 participants at risk
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure
|
|---|---|---|
|
Vascular disorders
Abdominal Bloating
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Investigations
Abnormal Lab Value
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Abrasion
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.21%
2/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Injury, poisoning and procedural complications
Air Embolus
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Allergic Drug Reaction
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Allergic Dye Reaction
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Blood and lymphatic system disorders
Anemias
|
1.7%
16/934 • 5 years
|
1.1%
10/944 • 5 years
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Arm Fracture
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Arteriovenous Malformation
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
0.43%
4/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Bacteremia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Bleeding
|
1.9%
18/934 • 5 years
|
1.3%
12/944 • 5 years
|
|
Vascular disorders
Blood Loss
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Blurred Vision
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Borderline Prolongation of QT Interval
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Skin and subcutaneous tissue disorders
Bruise/Purpura Simplex
|
2.8%
26/934 • 5 years
|
2.3%
22/944 • 5 years
|
|
Cardiac disorders
Cardiac Thrombus
|
1.5%
14/934 • 5 years
|
1.4%
13/944 • 5 years
|
|
Vascular disorders
Carotid Stenosis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Cellulitis
|
0.54%
5/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Cardiac disorders
Chest Pain
|
0.64%
6/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Nervous system disorders
Cognitive Impairment
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Confusion
|
0.32%
3/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
Congestive Heart Failure
|
0.54%
5/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Decreased Left Ventricular (LV) Function
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Deep Vein/Venous Thrombosis
|
0.11%
1/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Product Issues
Device Malposition or Malfunction
|
0.54%
5/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Diplopia/Double Vision
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Dysarthria/Slurred Speech
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Dyspnea
|
0.43%
4/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Investigations
Echo Finding
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Metabolism and nutrition disorders
Edema
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.11%
1/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Vascular disorders
Epistaxis
|
4.0%
37/934 • 5 years
|
3.5%
33/944 • 5 years
|
|
Vascular disorders
Eye Bleed
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.86%
8/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Fatigue/Generalized Fatigue
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Fever
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Fungal Infections
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
3.1%
29/934 • 5 years
|
3.9%
37/944 • 5 years
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.21%
2/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Hemarthrosis
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Hematoma
|
0.64%
6/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
2.4%
22/934 • 5 years
|
2.3%
22/944 • 5 years
|
|
Vascular disorders
Hemoptysis
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Nervous system disorders
Hemorrhage
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
Hemothorax
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Hepatobiliary disorders
Hepatic and Biliary Disorders
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Hypertensive Crisis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Hypotension
|
0.11%
1/934 • 5 years
|
0.53%
5/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Blood and lymphatic system disorders
Iron-Deficiency Anemia
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
Lacerations
|
0.64%
6/934 • 5 years
|
0.95%
9/944 • 5 years
|
|
Vascular disorders
Lightheadedness
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Loss of Speech/Stuttering
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Eye disorders
Macular Edema
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Memory Difficulty
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Migraine
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Neck Pain
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
New and Different Onset of Migraine Symptoms
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
General disorders
Non-Cardiac Chest Pain
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Numbness
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Other
|
0.32%
3/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
General disorders
Pain
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Paresthesia/Paraesthesia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Patent Foramen Ovale (PFO)
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Pericardial Effusion
|
2.1%
20/934 • 5 years
|
1.6%
15/944 • 5 years
|
|
Cardiac disorders
Pericarditis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Vascular disorders
Peripheral Venous Thrombus
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Infections and infestations
Phlebitis
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.11%
1/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritis/Itching
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Surgical and medical procedures
Residual Shunt
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Investigations
ST Segment Changes
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Bruise
|
0.32%
3/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin Lesions
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Sore Throat
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Nervous system disorders
Spells
|
0.43%
4/934 • 5 years
|
1.3%
12/944 • 5 years
|
|
Nervous system disorders
Subdural Haemorrhage
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Sustained Ventricular Tachycardia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Vascular disorders
Syncope
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Product Issues
Thrombus on Device
|
0.21%
2/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Nervous system disorders
Transient Global Amnesia
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.75%
7/934 • 5 years
|
0.42%
4/944 • 5 years
|
|
Injury, poisoning and procedural complications
Trauma
|
0.86%
8/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
|
0.21%
2/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Renal and urinary disorders
Urinary Retention
|
0.32%
3/934 • 5 years
|
0.32%
3/944 • 5 years
|
|
Renal and urinary disorders
Urinary Tract Infections
|
0.86%
8/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
VASC AV Fistula
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Bleeding
|
1.4%
13/934 • 5 years
|
1.3%
12/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Bruise
|
0.32%
3/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Hematoma
|
1.4%
13/934 • 5 years
|
2.0%
19/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Pain
|
0.11%
1/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Injury, poisoning and procedural complications
VASC Pseudoaneurysm
|
0.00%
0/934 • 5 years
|
0.21%
2/944 • 5 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
General disorders
Weakness
|
0.32%
3/934 • 5 years
|
0.11%
1/944 • 5 years
|
|
Cardiac disorders
Wenckebach (Mobitz I) Block
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.11%
1/934 • 5 years
|
0.00%
0/944 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER