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Trial record 1 of 1 for:    watchman | abbott [Lead]
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AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02879448
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Results First Posted : January 11, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Stroke
Interventions Device: Amulet Left Atrial Appendage Occluder
Device: WATCHMAN Left Atrial Appendage Closure
Enrollment 1878
Recruitment Details A total of 1878 subjects were randomized at 108 sites between September 8, 2016 and March 8, 2019. Subject enrollment into the Amulet IDE trial began on August 24, 2016 and the last subject enrollment was on March 8, 2019.
Pre-assignment Details 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.
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Period Title: Overall Study
Started 934 944
Completed 796 742
Not Completed 138 202
Reason Not Completed
No implant attempt             17             28
Withdrawal by Subject             20             46
Death             63             85
Lost to Follow-up             3             4
Missing visit             34             39
Pending evaluation             1             0
Arm/Group Title Amulet WATCHMAN (Control) Total
Hide Arm/Group Description

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Total of all reporting groups
Overall Number of Baseline Participants 934 944 1878
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 934 participants 944 participants 1878 participants
75.0  (7.6) 75.1  (7.6) 75.0  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 934 participants 944 participants 1878 participants
Female
385
  41.2%
365
  38.7%
750
  39.9%
Male
549
  58.8%
579
  61.3%
1128
  60.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 934 participants 944 participants 1878 participants
White
838
  89.7%
851
  90.1%
1689
  89.9%
Black or African American
21
   2.2%
20
   2.1%
41
   2.2%
Asian
4
   0.4%
7
   0.7%
11
   0.6%
American Indian or Alaska Native
4
   0.4%
2
   0.2%
6
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
3
   0.3%
3
   0.2%
Other
10
   1.1%
9
   1.0%
19
   1.0%
Declined or Unable to Disclose Due to Local Regulation
57
   6.1%
52
   5.5%
109
   5.8%
Hispanic or Latino
26
   2.8%
35
   3.7%
61
   3.2%
[1]
Measure Description: Participants were identified in both Race and Ethnicity
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 934 participants 944 participants 1878 participants
Canada 4 3 7
Europe 102 101 203
United States 792 806 1598
Australia 36 34 70
Number of Participants with History of Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 934 participants 944 participants 1878 participants
168
  18.0%
188
  19.9%
356
  19.0%
1.Primary Outcome
Title 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)
Hide Description

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
Time Frame At 12-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 903 896
Measure Type: Number
Unit of Measure: Percentage of participants
14.5 14.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments

The following hypothesis was tested:

H0: p1(Amulet) - p1 (Watchman) ≥ Δ1

H1: p1(Amulet) - p1(Watchman) < Δ1;

where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event.

Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
2.Primary Outcome
Title Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)
Hide Description

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.

Time Frame At 18-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 934 944
Measure Type: Number
Unit of Measure: Percentage of participants
2.8 2.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments

The following hypothesis was tested:

H0: p2(Amulet) - p2(Watchman) ≥ Δ2

H1: p2(Amulet) - p2(Watchman) < Δ2;

where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event.

Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
3.Primary Outcome
Title Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)
Hide Description 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.
Time Frame At 45-days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 801 792
Measure Type: Number
Unit of Measure: Percentage of participants
98.9 96.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments

The following hypothesis was tested:

H0: p3(Amulet) - p3(Watchman) ≤ -Δ3

H1: p3(Amulet) - p3(Watchman) > -Δ3;

where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability.

Type of Statistical Test Non-Inferiority
Comments The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet > 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Farrington Manning test
Comments [Not Specified]
4.Secondary Outcome
Title Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)
Hide Description

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
Time Frame At 18-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 915 916
Measure Type: Number
Unit of Measure: Percentage of participants
5.6 7.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

The following hypothesis was tested:

H1: p4(Amulet) - p4(Watchman) < 4.5%

Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
5.Secondary Outcome
Title Rate of Major Bleeding (Superiority Analysis)
Hide Description

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
Time Frame At 18-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 917 916
Measure Type: Number
Unit of Measure: Percentage of participants
11.6 12.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

The following hypothesis was tested:

H1: p5(Amulet) - p5(Watchman) < 0

Statistical Test of Hypothesis P-Value 0.3229
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
6.Secondary Outcome
Title 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)
Hide Description

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
Time Frame At 12-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 903 896
Measure Type: Number
Unit of Measure: percentage of participants
14.5 14.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

The following hypothesis was tested:

H1: p1(Amulet) - p1(Watchman) < 0

Statistical Test of Hypothesis P-Value 0.4660
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
7.Secondary Outcome
Title Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
Hide Description

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.

Time Frame At 18-months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 934 944
Measure Type: Number
Unit of Measure: Percentage of participants
2.8 2.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

The following hypothesis was tested:

H1: p2(Amulet) - p2(Watchman) < 0

Statistical Test of Hypothesis P-Value 0.5017
Comments [Not Specified]
Method Kaplan-Meier estimate
Comments [Not Specified]
8.Secondary Outcome
Title Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab
Hide Description 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.
Time Frame At 45-days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who were available at that time of analysis
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description:

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

Overall Number of Participants Analyzed 801 792
Measure Type: Number
Unit of Measure: Percentage of participants
98.9 96.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection WATCHMAN (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

The following hypothesis was tested:

H1: p3(Amulet) - p3(Watchman) > 0

Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method Farrington Manning test
Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amulet WATCHMAN (Control)
Hide Arm/Group Description

Amulet left atrial appendage occluder

Amulet Left Atrial Appendage Occluder: Transcatheter left atrial appendage closure

WATCHMAN left atrial appendage closure device

WATCHMAN Left Atrial Appendage Closure: Transcatheter left atrial appendage closure

All-Cause Mortality
Amulet WATCHMAN (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   63/934 (6.75%)   85/944 (9.00%) 
Hide Serious Adverse Events
Amulet WATCHMAN (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   426/934 (45.61%)   436/944 (46.19%) 
Blood and lymphatic system disorders     
Anemias  1  25/934 (2.68%)  16/944 (1.69%) 
Aplastic Anemia/Hypoplastic Anemia  1  2/934 (0.21%)  1/944 (0.11%) 
Iron-Deficiency Anemia  1  0/934 (0.00%)  2/944 (0.21%) 
Cardiac disorders     
AV Block  1  1/934 (0.11%)  0/944 (0.00%) 
Acute Pulmonary Edema  1  2/934 (0.21%)  0/944 (0.00%) 
Angina Pectoris  1  1/934 (0.11%)  5/944 (0.53%) 
Anterior Myocardial Infarction  1  2/934 (0.21%)  0/944 (0.00%) 
Aortic Aneurysms  1  3/934 (0.32%)  1/944 (0.11%) 
Aortic Dissection  1  1/934 (0.11%)  0/944 (0.00%) 
Aortic Valve Insufficiency/Aortic Valve Regurgitation/Valvular Regurgitation Aortic Valve  1  1/934 (0.11%)  1/944 (0.11%) 
Aortic Valve Stenosis  1  6/934 (0.64%)  4/944 (0.42%) 
Asystole  1  0/934 (0.00%)  1/944 (0.11%) 
Atrial Fibrillation  1  4/934 (0.43%)  5/944 (0.53%) 
Atrial Flutter  1  4/934 (0.43%)  1/944 (0.11%) 
Cardiac Arrest  1  15/934 (1.61%)  20/944 (2.12%) 
Cardiac Perforation  1  1/934 (0.11%)  1/944 (0.11%) 
Cardiac Thrombus  1  1/934 (0.11%)  1/944 (0.11%) 
Cardiogenic Shock  1  2/934 (0.21%)  0/944 (0.00%) 
Cardiomyopathy  1  1/934 (0.11%)  1/944 (0.11%) 
Chest Pain  1  12/934 (1.28%)  17/944 (1.80%) 
Congestive Heart Failure  1  84/934 (8.99%)  80/944 (8.47%) 
Constrictive Pericarditis  1  1/934 (0.11%)  0/944 (0.00%) 
Cor Pulmonale  1  0/934 (0.00%)  1/944 (0.11%) 
Coronary Artery Disease  1  9/934 (0.96%)  10/944 (1.06%) 
Coronary Artery Occlusion  1  1/934 (0.11%)  0/944 (0.00%) 
Dyspnea  1  4/934 (0.43%)  3/944 (0.32%) 
High Grade Block/Advanced AV Block  1  1/934 (0.11%)  1/944 (0.11%) 
Inferior Myocardial Infarction  1  1/934 (0.11%)  0/944 (0.00%) 
Mitral Valve Regurgitation/Mitral Insufficiency  1  9/934 (0.96%)  5/944 (0.53%) 
Myocardial Infarction  1  10/934 (1.07%)  13/944 (1.38%) 
Paroxysmal Atrial Fibrillation  1  0/934 (0.00%)  1/944 (0.11%) 
Pericardial Effusion  1  16/934 (1.71%)  6/944 (0.64%) 
Pericardial Tamponade  1  16/934 (1.71%)  14/944 (1.48%) 
Pericarditis  1  8/934 (0.86%)  2/944 (0.21%) 
Perivalvular Leak  1  0/934 (0.00%)  1/944 (0.11%) 
Regular Narrow QRS Tachycardia/Supraventricular Tachycardias  1  1/934 (0.11%)  0/944 (0.00%) 
Sick Sinus Syndrome  1  8/934 (0.86%)  6/944 (0.64%) 
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)  1  6/934 (0.64%)  4/944 (0.42%) 
Sinus Node Dysfunction  1  1/934 (0.11%)  0/944 (0.00%) 
Supravalvular Aortic Stenosis  1  1/934 (0.11%)  0/944 (0.00%) 
Sustained Ventricular Tachycardia  1  1/934 (0.11%)  2/944 (0.21%) 
Third Degree Heart Block (Complete Heart Block)  1  2/934 (0.21%)  3/944 (0.32%) 
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve  1  2/934 (0.21%)  2/944 (0.21%) 
Unstable Angina  1  3/934 (0.32%)  5/944 (0.53%) 
Ventricular Fibrillation  1  0/934 (0.00%)  1/944 (0.11%) 
Ventricular Tachycardia  1  3/934 (0.32%)  1/944 (0.11%) 
Other  1  2/934 (0.21%)  0/944 (0.00%) 
Eye disorders     
Retinal Hemorrhage  1  1/934 (0.11%)  0/944 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  3/934 (0.32%)  0/944 (0.00%) 
Acute Peritonitis  1  1/934 (0.11%)  1/944 (0.11%) 
Bowel Obstruction  1  2/934 (0.21%)  1/944 (0.11%) 
Colitis  1  1/934 (0.11%)  0/944 (0.00%) 
Diarrhea  1  0/934 (0.00%)  1/944 (0.11%) 
Diverticulitis  1  2/934 (0.21%)  1/944 (0.11%) 
Dysphagia  1  2/934 (0.21%)  0/944 (0.00%) 
Emesis/Vomiting  1  0/934 (0.00%)  1/944 (0.11%) 
Gastroenteritis  1  2/934 (0.21%)  0/944 (0.00%) 
Gastrointestinal Bleeding  1  67/934 (7.17%)  72/944 (7.63%) 
Hemorrhoids/Piles  1  1/934 (0.11%)  0/944 (0.00%) 
Nausea  1  1/934 (0.11%)  0/944 (0.00%) 
General disorders     
Chills/Rigors  1  0/934 (0.00%)  1/944 (0.11%) 
Damage or Movement of ICD Leads Requiring Revisions  1  1/934 (0.11%)  0/944 (0.00%) 
Drug Side Effect  1  1/934 (0.11%)  0/944 (0.00%) 
Failure to Thrive  1  1/934 (0.11%)  3/944 (0.32%) 
Fatigue/Generalized Fatigue  1  3/934 (0.32%)  1/944 (0.11%) 
Fever  1  0/934 (0.00%)  4/944 (0.42%) 
Multiple Organ Failure  1  3/934 (0.32%)  4/944 (0.42%) 
Neck Pain  1  0/934 (0.00%)  1/944 (0.11%) 
Non-Cardiac Chest Pain  1  3/934 (0.32%)  3/944 (0.32%) 
Weakness  1  3/934 (0.32%)  2/944 (0.21%) 
Other  1  2/934 (0.21%)  6/944 (0.64%) 
Hepatobiliary disorders     
Ascites  1  0/934 (0.00%)  1/944 (0.11%) 
Cholecystitis  1  0/934 (0.00%)  1/944 (0.11%) 
Choledocholithiasis  1  1/934 (0.11%)  0/944 (0.00%) 
Hepatic and Biliary Disorders  1  2/934 (0.21%)  1/944 (0.11%) 
Infections and infestations     
Acute Bacterial Endocarditis (ABE)  1  1/934 (0.11%)  0/944 (0.00%) 
Bacteremia  1  1/934 (0.11%)  1/944 (0.11%) 
Bacterial Infections  1  2/934 (0.21%)  0/944 (0.00%) 
Bronchitis  1  0/934 (0.00%)  1/944 (0.11%) 
Cellulitis  1  5/934 (0.54%)  4/944 (0.42%) 
Chlamydial Pneumonia  1  1/934 (0.11%)  0/944 (0.00%) 
Infected Cyst  1  0/934 (0.00%)  1/944 (0.11%) 
Influenza  1  1/934 (0.11%)  0/944 (0.00%) 
Pneumonia  1  11/934 (1.18%)  6/944 (0.64%) 
Respiratory Syncytial Virus Infection (RSV)  1  1/934 (0.11%)  0/944 (0.00%) 
Sepsis  1  9/934 (0.96%)  11/944 (1.17%) 
Septicemia  1  1/934 (0.11%)  0/944 (0.00%) 
Urinary Tract Infections  1  6/934 (0.64%)  7/944 (0.74%) 
Other  1  1/934 (0.11%)  0/944 (0.00%) 
Injury, poisoning and procedural complications     
Air Embolus  1  2/934 (0.21%)  2/944 (0.21%) 
Closed Head Injury  1  0/934 (0.00%)  2/944 (0.21%) 
Contusion  1  0/934 (0.00%)  1/944 (0.11%) 
Epidural Hematomas  1  1/934 (0.11%)  0/944 (0.00%) 
Esophageal Laceration and Rupture  1  1/934 (0.11%)  2/944 (0.21%) 
Fall  1  5/934 (0.54%)  12/944 (1.27%) 
Hemothorax  1  3/934 (0.32%)  0/944 (0.00%) 
Hip Fracture  1  0/934 (0.00%)  1/944 (0.11%) 
Trauma  1  9/934 (0.96%)  10/944 (1.06%) 
VASC Bleeding  1  1/934 (0.11%)  3/944 (0.32%) 
VASC Hematoma  1  3/934 (0.32%)  8/944 (0.85%) 
VASC Pseudoaneurysm  1  1/934 (0.11%)  4/944 (0.42%) 
VASC Vessel Perforation  1  1/934 (0.11%)  1/944 (0.11%) 
Investigations     
Abnormal Coagulation Parameter  1  0/934 (0.00%)  4/944 (0.42%) 
Abnormal Lab Value  1  1/934 (0.11%)  4/944 (0.42%) 
EKG Abnormalities  1  1/934 (0.11%)  0/944 (0.00%) 
Echo Finding  1  0/934 (0.00%)  1/944 (0.11%) 
Metabolism and nutrition disorders     
Dehydration  1  2/934 (0.21%)  1/944 (0.11%) 
Diabetic Ketoacidosis  1  0/934 (0.00%)  1/944 (0.11%) 
Edema  1  0/934 (0.00%)  1/944 (0.11%) 
Hyperglycemia  1  1/934 (0.11%)  0/944 (0.00%) 
Hyperkalemia  1  0/934 (0.00%)  1/944 (0.11%) 
Hypervolemia  1  1/934 (0.11%)  0/944 (0.00%) 
Hypoglycemia  1  0/934 (0.00%)  1/944 (0.11%) 
Hyponatremia  1  1/934 (0.11%)  0/944 (0.00%) 
Metabolic Acidosis  1  1/934 (0.11%)  0/944 (0.00%) 
Musculoskeletal and connective tissue disorders     
Spinal Stenosis  1  1/934 (0.11%)  0/944 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer  1  6/934 (0.64%)  6/944 (0.64%) 
Colon Cancer  1  0/934 (0.00%)  1/944 (0.11%) 
Leukemias  1  4/934 (0.43%)  1/944 (0.11%) 
Lung Cancer  1  2/934 (0.21%)  1/944 (0.11%) 
Pancreatic Cancer  1  1/934 (0.11%)  1/944 (0.11%) 
Thyroid Cancer  1  1/934 (0.11%)  0/944 (0.00%) 
Nervous system disorders     
Acute Subdural Hematoma  1  1/934 (0.11%)  1/944 (0.11%) 
Altered Sensorium  1  0/934 (0.00%)  2/944 (0.21%) 
Ataxia  1  0/934 (0.00%)  1/944 (0.11%) 
Bells Palsy  1  0/934 (0.00%)  1/944 (0.11%) 
Blurred Vision  1  0/934 (0.00%)  1/944 (0.11%) 
Cerebral Aneurysm  1  1/934 (0.11%)  1/944 (0.11%) 
Concussion  1  0/934 (0.00%)  1/944 (0.11%) 
Delirium  1  2/934 (0.21%)  3/944 (0.32%) 
Dementia  1  0/934 (0.00%)  2/944 (0.21%) 
Dizziness  1  3/934 (0.32%)  2/944 (0.21%) 
Dysphasia  1  0/934 (0.00%)  1/944 (0.11%) 
Encephalopathy  1  10/934 (1.07%)  11/944 (1.17%) 
Hypertensive Encephalopathy  1  1/934 (0.11%)  0/944 (0.00%) 
Intracerebral Hemorrhage  1  5/934 (0.54%)  4/944 (0.42%) 
Ischemic Stroke  1  22/934 (2.36%)  23/944 (2.44%) 
Microhemorrhage  1  0/934 (0.00%)  1/944 (0.11%) 
Migraine  1  1/934 (0.11%)  1/944 (0.11%) 
Neuralgic Facial Pain  1  1/934 (0.11%)  0/944 (0.00%) 
New and Different Onset of Migraine Symptoms  1  1/934 (0.11%)  0/944 (0.00%) 
Numbness  1  1/934 (0.11%)  0/944 (0.00%) 
Parkinson's Disease  1  2/934 (0.21%)  1/944 (0.11%) 
Radiculopathy  1  0/934 (0.00%)  2/944 (0.21%) 
Seizure Disorder  1  2/934 (0.21%)  0/944 (0.00%) 
Seizure/Convulsions/Epilepsy  1  6/934 (0.64%)  6/944 (0.64%) 
Spells  1  4/934 (0.43%)  6/944 (0.64%) 
Subarachnoid Hemorrhage  1  0/934 (0.00%)  1/944 (0.11%) 
Subdural Hemorrhage  1  0/934 (0.00%)  3/944 (0.32%) 
Transient Global Amnesia  1  1/934 (0.11%)  0/944 (0.00%) 
Transient Ischemic Attack (TIA)  1  11/934 (1.18%)  11/944 (1.17%) 
Vertigo  1  2/934 (0.21%)  2/944 (0.21%) 
Product Issues     
Device Embolization  1  6/934 (0.64%)  2/944 (0.21%) 
Device Malposition or Malfunction  1  1/934 (0.11%)  7/944 (0.74%) 
Thrombus on Device  1  1/934 (0.11%)  0/944 (0.00%) 
Psychiatric disorders     
Suicide Attempt  1  1/934 (0.11%)  0/944 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury  1  8/934 (0.86%)  7/944 (0.74%) 
Chronic Renal Failure  1  0/934 (0.00%)  1/944 (0.11%) 
Cystitis  1  0/934 (0.00%)  1/944 (0.11%) 
Hematuria  1  8/934 (0.86%)  8/944 (0.85%) 
Nephrolithiasis  1  1/934 (0.11%)  0/944 (0.00%) 
Renal Infarct  1  0/934 (0.00%)  1/944 (0.11%) 
Urinary Calculi  1  1/934 (0.11%)  0/944 (0.00%) 
Urinary Retention  1  1/934 (0.11%)  2/944 (0.21%) 
Reproductive system and breast disorders     
Ovarian Cyst  1  1/934 (0.11%)  0/944 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/934 (0.11%)  0/944 (0.00%) 
Chronic Obstructive Pulmonary Disease (COPD)  1  1/934 (0.11%)  7/944 (0.74%) 
Hypoxemia  1  1/934 (0.11%)  1/944 (0.11%) 
Hypoxia  1  0/934 (0.00%)  1/944 (0.11%) 
Idiopathic Interstitial Lung Diseases  1  1/934 (0.11%)  1/944 (0.11%) 
Pleural Effusion  1  8/934 (0.86%)  7/944 (0.74%) 
Pulmonary Embolism  1  9/934 (0.96%)  6/944 (0.64%) 
Pulmonary Hypertension  1  0/934 (0.00%)  1/944 (0.11%) 
Respiratory Failure  1  9/934 (0.96%)  16/944 (1.69%) 
Skin and subcutaneous tissue disorders     
Skin Ulcer  1  0/934 (0.00%)  1/944 (0.11%) 
Surgical and medical procedures     
Residual Shunt Requiring Closure  1  1/934 (0.11%)  1/944 (0.11%) 
Surgical Closure of ASD  1  1/934 (0.11%)  1/944 (0.11%) 
Other  1  1/934 (0.11%)  0/944 (0.00%) 
Vascular disorders     
Abdominal Bleeding  1  1/934 (0.11%)  0/944 (0.00%) 
Arterial Hypertension/Hypertension  1  2/934 (0.21%)  4/944 (0.42%) 
Bleeding  1  6/934 (0.64%)  5/944 (0.53%) 
Blood Loss  1  2/934 (0.21%)  1/944 (0.11%) 
Carotid Stenosis  1  4/934 (0.43%)  0/944 (0.00%) 
Deep Vein/Venous Thrombosis  1  7/934 (0.75%)  5/944 (0.53%) 
Epistaxis  1  11/934 (1.18%)  3/944 (0.32%) 
Hematoma  1  2/934 (0.21%)  8/944 (0.85%) 
Hemoptysis  1  2/934 (0.21%)  3/944 (0.32%) 
Hypotension  1  6/934 (0.64%)  7/944 (0.74%) 
Orthostatic Hypotension  1  1/934 (0.11%)  0/944 (0.00%) 
Peripheral Arterial Occlusion  1  3/934 (0.32%)  0/944 (0.00%) 
Peripheral Vascular Disease  1  5/934 (0.54%)  1/944 (0.11%) 
Peripheral Venous Thrombus  1  1/934 (0.11%)  1/944 (0.11%) 
Syncope  1  13/934 (1.39%)  16/944 (1.69%) 
Systemic Embolism  1  2/934 (0.21%)  1/944 (0.11%) 
Vascular Ischemia  1  1/934 (0.11%)  0/944 (0.00%) 
1
Term from vocabulary, MedDRA 18
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amulet WATCHMAN (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/934 (0.00%)   0/944 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jordan Anderson, Clinical Scientist
Organization: Abbott Medical
Phone: 651 756 3360
EMail: ClinicalTrials.gov_SH_Inquiries@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02879448    
Other Study ID Numbers: SJM-CIP-10114
First Submitted: August 22, 2016
First Posted: August 25, 2016
Results First Submitted: November 9, 2021
Results First Posted: January 11, 2022
Last Update Posted: July 11, 2022