Amulet IDE: AMPLATZER™ Amulet™ LAA Occluder Trial

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02879448
• Collaborator: (none)
• Enrollment: 1,878
• Locations: 115
• Arms: 2
• Duration (Months): 92.2
• Patients Per Site: 16.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Amulet Left Atrial Appendage Occluder; Device: WATCHMAN Left Atrial Appendage Closure	N/A

Detailed Description

The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. Subjects will be randomized in a 1:1 ratio between the Amulet left atrial appendage (LAA) occlusion device (treatment) or a Boston Scientific WATCHMAN® LAA closure device (Control). The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1878 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial
• Study Start Date: Aug 24, 2016
• Actual Primary Completion Date: Dec 7, 2020
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amulet Amulet left atrial appendage occluder	Device: Amulet Left Atrial Appendage Occluder; Transcatheter left atrial appendage closure
Active Comparator: WATCHMAN (Control) WATCHMAN left atrial appendage closure device	Device: WATCHMAN Left Atrial Appendage Closure; Transcatheter left atrial appendage closure

Outcome Measures

Primary Outcome Measures

1. 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) [At 12-months]

   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

2. Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis) [At 18-months]

   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.

3. Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) [At 45-days]

   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.

Secondary Outcome Measures

1. Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis) [At 18-months]

   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

2. Rate of Major Bleeding (Superiority Analysis) [At 18-months]

   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

3. 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) [At 12-months]

   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

4. Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism [At 18-months]

   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.

5. Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab [At 45-days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age or older

2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease

3. At high risk of stroke or systemic embolism defined as CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3

4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication

5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation, following the conclusion of shared decision making (see inclusion criteria #6)

6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)

7. Able to comply with the required medication regimen post-device implant

8. Able to understand and willing to provide written informed consent to participate in the trial

9. Able and willing to return for required follow-up visits and examinations

Exclusion Criteria:

1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation

2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use

3. Indicated for chronic P2Y12 platelet therapy inhibitor

4. Is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay (criterion is only applicable where general anesthesia is planned for the study procedure).

5. Has undergone atrial septal defect (ASD) repair or has an ASD closure device present

6. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted

7. Implanted with a mechanical valve prosthesis

8. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)

9. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)

10. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure (e.g. cardioversion, ablation, cataract surgery, etc.)

11. Myocardial infarction (MI) within 90 days prior to randomization

12. New York Heart Association Class IV Congestive Heart Failure

13. Left ventricular ejection Fraction (LVEF) ≤30%

14. Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis

15. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)

16. History of idiopathic or recurrent venous thromboembolism

17. Left atrial appendage is obliterated or surgically ligated

18. Thrombocytopenia or anemia requiring transfusions

19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)

20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial

21. Subject is pregnant or pregnancy is planned during the course of the investigation

22. Active endocarditis or other infection producing bacteremia

23. Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)

24. Subjects with severe renal failure (estimated glomerular filtration rate <30ml/min/1.73m²)

25. Subject whose life expectancy is less than 2 years

26. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.

Echocardiographic Exclusion Criteria:

1. Intracardiac thrombus visualized by echocardiographic imaging

2. Existing circumferential pericardial effusion >2mm

3. Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm^2)

4. High risk PFO, defined as an atrial septal aneurysm (excursion > 15mm or length ≥ 15mm; excursion defined as maximal protrusion of the atrial septal aneurysm [ASA] beyond the plane of the atrial septum) or large shunt (early, within 3 beats and/or substantial passage of bubbles i.e. ≥ 20)

5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch

6. Cardiac tumor

7. LAA anatomy cannot accommodate either a Boston Scientific LAA closure device or Amulet device, as per manufacturer's Instructions for Use (IFU). (i.e. the LAA anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial. This is applicable to all roll-in and randomized subjects).

8. Placement of the device would interfere with any intracardiac or intravascular structure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research, LLC.	Huntsville	Alabama	United States	35801
2	Banner-University Medical Center Phoenix	Phoenix	Arizona	United States	85006
3	Arizona Cardiovascular Research Center	Phoenix	Arizona	United States	85016
4	St. Bernards Medical Center	Jonesboro	Arkansas	United States	72401
5	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
6	Scripps Health	La Jolla	California	United States	92037
7	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
8	USC University Hospital	Los Angeles	California	United States	90033-5313
9	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
10	El Camino Hospital	Mountain View	California	United States	94040
11	University of California - Davis Medical Center	Sacramento	California	United States	95817
12	Mercy Medical Group - Cardiology	Sacramento	California	United States	95819
13	San Diego Cardiac Center	San Diego	California	United States	92123
14	Pacific Heart Institute	Santa Monica	California	United States	90404
15	South Denver Cardiology Associates PC	Littleton	Colorado	United States	80120
16	Medical Center of the Rockies	Loveland	Colorado	United States	80538
17	Washington Hospital Center	Washington	District of Columbia	United States	20010
18	Bradenton Cardiology Center	Bradenton	Florida	United States	34205
19	Delray Medical Center	Delray Beach	Florida	United States	33484
20	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
21	Baptist Medical Center	Jacksonville	Florida	United States	32207
22	Watson Clinic Center	Lakeland	Florida	United States	33805
23	Baptist Hospital of Miami	Miami	Florida	United States	33176
24	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
25	Emory University Hospital	Atlanta	Georgia	United States	30322
26	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
27	The Queen's Medical Center	Honolulu	Hawaii	United States	96813
28	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
29	Rush University Medical Center	Chicago	Illinois	United States	60612
30	Midwest Cardiovascular Institute	Naperville	Illinois	United States	60540
31	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
32	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois	United States	60181
33	St. Vincent Hospital	Indianapolis	Indiana	United States	46240-0970
34	Kansas University Medical Center	Kansas City	Kansas	United States	66160
35	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas	United States	66211
36	Cardiovascular Research Institute of Kansas	Wichita	Kansas	United States	67226
37	Baptist Health Lexington	Lexington	Kentucky	United States	40503
38	University of Kentucky	Lexington	Kentucky	United States	40536
39	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
40	Lahey Clinic Medical Center	Burlington	Massachusetts	United States	01805
41	Charlton Memorial Hospital	Fall River	Massachusetts	United States	02720
42	Henry Ford Hospital	Detroit	Michigan	United States	48202
43	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
44	Beaumont Hospital, Royal Oak	Royal Oak	Michigan	United States	48073
45	VA Medical Center Minneapolis	Minneapolis	Minnesota	United States	55417
46	St. Cloud Hospital (Central MN Heart Clinic)	Saint Cloud	Minnesota	United States	56303
47	St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
48	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
49	St. Luke's Hospital	Kansas City	Missouri	United States	64111
50	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
51	Cooper University Hospital	Camden	New Jersey	United States	08103
52	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601-1901
53	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
54	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
55	Albany Medical Center	Albany	New York	United States	12208
56	Winthrop-University Hospital	Mineola	New York	United States	11501
57	New York University Hospital	New York	New York	United States	10016
58	Mount Sinai Hospital	New York	New York	United States	10019
59	New York Presbyterian/Columbia University Medical Center	New York	New York	United States	10032
60	Mission Health & Hospitals	Asheville	North Carolina	United States	28801
61	Wake Forest University Medical Center Clinical Sciences	Winston-Salem	North Carolina	United States	27157-1045
62	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
63	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
64	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma	United States	74104
65	Legacy Emanuel Hospital and Health Center	Portland	Oregon	United States	97227
66	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
67	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
68	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania	United States	19096
69	WellSpan Health	York	Pennsylvania	United States	17403-3676
70	Roper Hospital	Charleston	South Carolina	United States	29401
71	Medical University of South Carolina	Charleston	South Carolina	United States	29425
72	St. Thomas Hospital	Nashville	Tennessee	United States	37205
73	Vanderbilt Heart Institute	Nashville	Tennessee	United States	37212
74	Texas Cardiac Arrhythmia	Austin	Texas	United States	78705
75	Austin Heart	Austin	Texas	United States	78756
76	The Methodist Hospital	Houston	Texas	United States	77030
77	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
78	South Texas Cardiovascular Consultants	San Antonio	Texas	United States	78201
79	University of Utah Hospital	Salt Lake City	Utah	United States	84132
80	University of Vermont College of Medicine	Burlington	Vermont	United States	05405-0068
81	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
82	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
83	Swedish Medical Center	Seattle	Washington	United States	98107
84	West Virginia University Hospital	Morgantown	West Virginia	United States	26506
85	Aurora Medical Group	Milwaukee	Wisconsin	United States	53215
86	Specialist Cardiology	Wahroonga	New South Wales	Australia	2076
87	Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
88	St. Andrew's Hospital	Adelaide	South Australia	Australia	5000
89	HeartCare St John of God Wexford Medical Centre	Murdoch	Western Australia	Australia	6150
90	Vancouver General Hospital (U of BC)	Vancouver	British Columbia	Canada	V5Z 1M9
91	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec	Canada	H1T 1C8
92	Nemocnice Na Homolce	Prague	Central Bohemia	Czechia	15030
93	Skejby University Hospital	Arhus		Denmark	8200
94	Rigshospitalet	Copenhagen		Denmark	2100
95	Kliniken Villingen-Schwenningen	Villingen-Schwenningen	Bad-wur	Germany	78052
96	Klinikum Coburg GmbH	Coburg	Bavaria	Germany	96450
97	Internistisches Klinikum München SUD	Munich	Bavaria	Germany	81379
98	Cardioangiologisches Centrum am Bethanien Krankenhaus	Frankfurt	Hesse	Germany	60389
99	CardioVaskuläres Centrum St. Katharinen	Frankfurt	Hesse	Germany	60389
100	Evangelisches Krankenhaus Bielefeld	Bielefeld	North Rhine	Germany	33617
101	Medizinische Einrichtungen der Universität Düsseldorf	Dusseldorf	North Rhine	Germany	40225
102	Elisabeth-Krankenhaus Essen GmbH	Essen	North Rhin	Germany	45138
103	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz	Rhineland	Germany	55131
104	Herzzentrum Leipzig GmbH	Leipzig	Saxony	Germany	04289
105	Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin		Germany	12200
106	Asklepios Klinik St. Georg	Hamburg		Germany	20099
107	Ospedale San Raffaele - Aritmologia	Milano	Lombard	Italy	20132
108	St. Antonius Ziekenhuis	Nieuwegein	Utrecht	Netherlands	3435 CM
109	Santa Maria Hospital	Lisboa	Lisbon	Portugal	1649-035
110	Hospital Universitario Virgen Macarena	Sevilla	Andalusia	Spain	41007
111	Hospital General Juan Ramon Jimenez	Huelva	Andalu	Spain	21005
112	Hospital Universitario de Salamanca	Salamanca	Castile And Leon	Spain	37007
113	Hospital de la Santa Creu I Sant Pau	Barcelona	Catalonia	Spain	08025
114	Clínica Universidad de Navarra	Pamplona	Navarre	Spain	31008
115	Center Inselspital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: Dhanunjaya Lakkireddy, MD, University of Kansas
• Study Chair: David Thaler, MD, PhD, The Comprehensive Stroke Center at Tufts Medical Center
• Study Chair: Stephan Windecker, MD, PhD, Inselspital, University of Bern

Study Documents (Full-Text)

• Study Protocol - Dec 18, 2017
• Statistical Analysis Plan - Sep 21, 2017

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02879448
• Other Study ID Numbers: SJM-CIP-10114
• First Posted: Aug 25, 2016
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: Non-valvular atrial fibrillation; Left Atrial Appendage

Study Results

Participant Flow

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 Detail	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)
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

Baseline Characteristics

Arm/Group Title	Amulet	WATCHMAN (Control)	Total
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 Participants	934	944	1878
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.0 (7.6)	75.1 (7.6)	75.0 (7.6)
Sex: Female, Male (Count of Participants)
Female	385 41.2%	365 38.7%	750 39.9%
Male	549 58.8%	579 61.3%	1128 60.1%
Race/Ethnicity, Customized (Count of 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%	3 0.3%	3 0.2%
Other	10 1.1%	9 1%	19 1%
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%
Region of Enrollment (participants) [Number]
Canada	4 0.4%	3 0.3%	7 0.4%
Europe	102 10.9%	101 10.7%	203 10.8%
United States	792 84.8%	806 85.4%	1598 85.1%
Australia	36 3.9%	34 3.6%	70 3.7%
Number of Participants with History of Stroke (Count of Participants)
Count of Participants [Participants]	168 18%	188 19.9%	356 19%

Outcome Measures

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)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	903	896
Number [Percentage of participants]	14.5 1.6%	14.7 1.6%

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
	Method	Kaplan-Meier estimate
	Comments

2. Primary Outcome

Title	Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	934	944
Number [Percentage of participants]	2.8 0.3%	2.8 0.3%

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
	Method	Kaplan-Meier estimate
	Comments

3. Primary Outcome

Title	Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	801	792
Number [Percentage of participants]	98.9 10.6%	96.8 10.3%

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
	Method	Farrington Manning test
	Comments

4. Secondary Outcome

Title	Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	915	916
Number [Percentage of participants]	5.6 0.6%	7.7 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WATCHMAN (Control)
	Comments
	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
	Method	Kaplan-Meier estimate
	Comments

5. Secondary Outcome

Title	Rate of Major Bleeding (Superiority Analysis)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	917	916
Number [Percentage of participants]	11.6 1.2%	12.3 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WATCHMAN (Control)
	Comments
	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
	Method	Kaplan-Meier estimate
	Comments

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)
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	903	896
Number [percentage of participants]	14.5 1.6%	14.7 1.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WATCHMAN (Control)
	Comments
	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
	Method	Kaplan-Meier estimate
	Comments

7. Secondary Outcome

Title	Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	934	944
Number [Percentage of participants]	2.8 0.3%	2.8 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WATCHMAN (Control)
	Comments
	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
	Method	Kaplan-Meier estimate
	Comments

8. Secondary Outcome

Title	Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab
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

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who were available at that time of analysis

Arm/Group Title	Amulet	WATCHMAN (Control)
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
Measure Participants	801	792
Number [Percentage of participants]	98.9 10.6%	96.8 10.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	WATCHMAN (Control)
	Comments
	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
	Method	Farrington Manning test
	Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Amulet		WATCHMAN (Control)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	63/934 (6.7%)		85/944 (9%)
Serious Adverse Events
	Amulet		WATCHMAN (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	426/934 (45.6%)		436/944 (46.2%)
Blood and lymphatic system disorders
Anemias	25/934 (2.7%)		16/944 (1.7%)
Aplastic Anemia/Hypoplastic Anemia	2/934 (0.2%)		1/944 (0.1%)
Iron-Deficiency Anemia	0/934 (0%)		2/944 (0.2%)
Cardiac disorders
AV Block	1/934 (0.1%)		0/944 (0%)
Acute Pulmonary Edema	2/934 (0.2%)		0/944 (0%)
Angina Pectoris	1/934 (0.1%)		5/944 (0.5%)
Anterior Myocardial Infarction	2/934 (0.2%)		0/944 (0%)
Aortic Aneurysms	3/934 (0.3%)		1/944 (0.1%)
Aortic Dissection	1/934 (0.1%)		0/944 (0%)
Aortic Valve Insufficiency/Aortic Valve Regurgitation/Valvular Regurgitation Aortic Valve	1/934 (0.1%)		1/944 (0.1%)
Aortic Valve Stenosis	6/934 (0.6%)		4/944 (0.4%)
Asystole	0/934 (0%)		1/944 (0.1%)
Atrial Fibrillation	4/934 (0.4%)		5/944 (0.5%)
Atrial Flutter	4/934 (0.4%)		1/944 (0.1%)
Cardiac Arrest	15/934 (1.6%)		20/944 (2.1%)
Cardiac Perforation	1/934 (0.1%)		1/944 (0.1%)
Cardiac Thrombus	1/934 (0.1%)		1/944 (0.1%)
Cardiogenic Shock	2/934 (0.2%)		0/944 (0%)
Cardiomyopathy	1/934 (0.1%)		1/944 (0.1%)
Chest Pain	12/934 (1.3%)		17/944 (1.8%)
Congestive Heart Failure	84/934 (9%)		80/944 (8.5%)
Constrictive Pericarditis	1/934 (0.1%)		0/944 (0%)
Cor Pulmonale	0/934 (0%)		1/944 (0.1%)
Coronary Artery Disease	9/934 (1%)		10/944 (1.1%)
Coronary Artery Occlusion	1/934 (0.1%)		0/944 (0%)
Dyspnea	4/934 (0.4%)		3/944 (0.3%)
High Grade Block/Advanced AV Block	1/934 (0.1%)		1/944 (0.1%)
Inferior Myocardial Infarction	1/934 (0.1%)		0/944 (0%)
Mitral Valve Regurgitation/Mitral Insufficiency	9/934 (1%)		5/944 (0.5%)
Myocardial Infarction	10/934 (1.1%)		13/944 (1.4%)
Paroxysmal Atrial Fibrillation	0/934 (0%)		1/944 (0.1%)
Pericardial Effusion	16/934 (1.7%)		6/944 (0.6%)
Pericardial Tamponade	16/934 (1.7%)		14/944 (1.5%)
Pericarditis	8/934 (0.9%)		2/944 (0.2%)
Perivalvular Leak	0/934 (0%)		1/944 (0.1%)
Regular Narrow QRS Tachycardia/Supraventricular Tachycardias	1/934 (0.1%)		0/944 (0%)
Sick Sinus Syndrome	8/934 (0.9%)		6/944 (0.6%)
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	6/934 (0.6%)		4/944 (0.4%)
Sinus Node Dysfunction	1/934 (0.1%)		0/944 (0%)
Supravalvular Aortic Stenosis	1/934 (0.1%)		0/944 (0%)
Sustained Ventricular Tachycardia	1/934 (0.1%)		2/944 (0.2%)
Third Degree Heart Block (Complete Heart Block)	2/934 (0.2%)		3/944 (0.3%)
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve	2/934 (0.2%)		2/944 (0.2%)
Unstable Angina	3/934 (0.3%)		5/944 (0.5%)
Ventricular Fibrillation	0/934 (0%)		1/944 (0.1%)
Ventricular Tachycardia	3/934 (0.3%)		1/944 (0.1%)
Other	2/934 (0.2%)		0/944 (0%)
Eye disorders
Retinal Hemorrhage	1/934 (0.1%)		0/944 (0%)
Gastrointestinal disorders
Abdominal Pain	3/934 (0.3%)		0/944 (0%)
Acute Peritonitis	1/934 (0.1%)		1/944 (0.1%)
Bowel Obstruction	2/934 (0.2%)		1/944 (0.1%)
Colitis	1/934 (0.1%)		0/944 (0%)
Diarrhea	0/934 (0%)		1/944 (0.1%)
Diverticulitis	2/934 (0.2%)		1/944 (0.1%)
Dysphagia	2/934 (0.2%)		0/944 (0%)
Emesis/Vomiting	0/934 (0%)		1/944 (0.1%)
Gastroenteritis	2/934 (0.2%)		0/944 (0%)
Gastrointestinal Bleeding	67/934 (7.2%)		72/944 (7.6%)
Hemorrhoids/Piles	1/934 (0.1%)		0/944 (0%)
Nausea	1/934 (0.1%)		0/944 (0%)
General disorders
Chills/Rigors	0/934 (0%)		1/944 (0.1%)
Damage or Movement of ICD Leads Requiring Revisions	1/934 (0.1%)		0/944 (0%)
Drug Side Effect	1/934 (0.1%)		0/944 (0%)
Failure to Thrive	1/934 (0.1%)		3/944 (0.3%)
Fatigue/Generalized Fatigue	3/934 (0.3%)		1/944 (0.1%)
Fever	0/934 (0%)		4/944 (0.4%)
Multiple Organ Failure	3/934 (0.3%)		4/944 (0.4%)
Neck Pain	0/934 (0%)		1/944 (0.1%)
Non-Cardiac Chest Pain	3/934 (0.3%)		3/944 (0.3%)
Weakness	3/934 (0.3%)		2/944 (0.2%)
Other	2/934 (0.2%)		6/944 (0.6%)
Hepatobiliary disorders
Ascites	0/934 (0%)		1/944 (0.1%)
Cholecystitis	0/934 (0%)		1/944 (0.1%)
Choledocholithiasis	1/934 (0.1%)		0/944 (0%)
Hepatic and Biliary Disorders	2/934 (0.2%)		1/944 (0.1%)
Infections and infestations
Acute Bacterial Endocarditis (ABE)	1/934 (0.1%)		0/944 (0%)
Bacteremia	1/934 (0.1%)		1/944 (0.1%)
Bacterial Infections	2/934 (0.2%)		0/944 (0%)
Bronchitis	0/934 (0%)		1/944 (0.1%)
Cellulitis	5/934 (0.5%)		4/944 (0.4%)
Chlamydial Pneumonia	1/934 (0.1%)		0/944 (0%)
Infected Cyst	0/934 (0%)		1/944 (0.1%)
Influenza	1/934 (0.1%)		0/944 (0%)
Pneumonia	11/934 (1.2%)		6/944 (0.6%)
Respiratory Syncytial Virus Infection (RSV)	1/934 (0.1%)		0/944 (0%)
Sepsis	9/934 (1%)		11/944 (1.2%)
Septicemia	1/934 (0.1%)		0/944 (0%)
Urinary Tract Infections	6/934 (0.6%)		7/944 (0.7%)
Other	1/934 (0.1%)		0/944 (0%)
Injury, poisoning and procedural complications
Air Embolus	2/934 (0.2%)		2/944 (0.2%)
Closed Head Injury	0/934 (0%)		2/944 (0.2%)
Contusion	0/934 (0%)		1/944 (0.1%)
Epidural Hematomas	1/934 (0.1%)		0/944 (0%)
Esophageal Laceration and Rupture	1/934 (0.1%)		2/944 (0.2%)
Fall	5/934 (0.5%)		12/944 (1.3%)
Hemothorax	3/934 (0.3%)		0/944 (0%)
Hip Fracture	0/934 (0%)		1/944 (0.1%)
Trauma	9/934 (1%)		10/944 (1.1%)
VASC Bleeding	1/934 (0.1%)		3/944 (0.3%)
VASC Hematoma	3/934 (0.3%)		8/944 (0.8%)
VASC Pseudoaneurysm	1/934 (0.1%)		4/944 (0.4%)
VASC Vessel Perforation	1/934 (0.1%)		1/944 (0.1%)
Investigations
Abnormal Coagulation Parameter	0/934 (0%)		4/944 (0.4%)
Abnormal Lab Value	1/934 (0.1%)		4/944 (0.4%)
EKG Abnormalities	1/934 (0.1%)		0/944 (0%)
Echo Finding	0/934 (0%)		1/944 (0.1%)
Metabolism and nutrition disorders
Dehydration	2/934 (0.2%)		1/944 (0.1%)
Diabetic Ketoacidosis	0/934 (0%)		1/944 (0.1%)
Edema	0/934 (0%)		1/944 (0.1%)
Hyperglycemia	1/934 (0.1%)		0/944 (0%)
Hyperkalemia	0/934 (0%)		1/944 (0.1%)
Hypervolemia	1/934 (0.1%)		0/944 (0%)
Hypoglycemia	0/934 (0%)		1/944 (0.1%)
Hyponatremia	1/934 (0.1%)		0/944 (0%)
Metabolic Acidosis	1/934 (0.1%)		0/944 (0%)
Musculoskeletal and connective tissue disorders
Spinal Stenosis	1/934 (0.1%)		0/944 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	6/934 (0.6%)		6/944 (0.6%)
Colon Cancer	0/934 (0%)		1/944 (0.1%)
Leukemias	4/934 (0.4%)		1/944 (0.1%)
Lung Cancer	2/934 (0.2%)		1/944 (0.1%)
Pancreatic Cancer	1/934 (0.1%)		1/944 (0.1%)
Thyroid Cancer	1/934 (0.1%)		0/944 (0%)
Nervous system disorders
Acute Subdural Hematoma	1/934 (0.1%)		1/944 (0.1%)
Altered Sensorium	0/934 (0%)		2/944 (0.2%)
Ataxia	0/934 (0%)		1/944 (0.1%)
Bells Palsy	0/934 (0%)		1/944 (0.1%)
Blurred Vision	0/934 (0%)		1/944 (0.1%)
Cerebral Aneurysm	1/934 (0.1%)		1/944 (0.1%)
Concussion	0/934 (0%)		1/944 (0.1%)
Delirium	2/934 (0.2%)		3/944 (0.3%)
Dementia	0/934 (0%)		2/944 (0.2%)
Dizziness	3/934 (0.3%)		2/944 (0.2%)
Dysphasia	0/934 (0%)		1/944 (0.1%)
Encephalopathy	10/934 (1.1%)		11/944 (1.2%)
Hypertensive Encephalopathy	1/934 (0.1%)		0/944 (0%)
Intracerebral Hemorrhage	5/934 (0.5%)		4/944 (0.4%)
Ischemic Stroke	22/934 (2.4%)		23/944 (2.4%)
Microhemorrhage	0/934 (0%)		1/944 (0.1%)
Migraine	1/934 (0.1%)		1/944 (0.1%)
Neuralgic Facial Pain	1/934 (0.1%)		0/944 (0%)
New and Different Onset of Migraine Symptoms	1/934 (0.1%)		0/944 (0%)
Numbness	1/934 (0.1%)		0/944 (0%)
Parkinson's Disease	2/934 (0.2%)		1/944 (0.1%)
Radiculopathy	0/934 (0%)		2/944 (0.2%)
Seizure Disorder	2/934 (0.2%)		0/944 (0%)
Seizure/Convulsions/Epilepsy	6/934 (0.6%)		6/944 (0.6%)
Spells	4/934 (0.4%)		6/944 (0.6%)
Subarachnoid Hemorrhage	0/934 (0%)		1/944 (0.1%)
Subdural Hemorrhage	0/934 (0%)		3/944 (0.3%)
Transient Global Amnesia	1/934 (0.1%)		0/944 (0%)
Transient Ischemic Attack (TIA)	11/934 (1.2%)		11/944 (1.2%)
Vertigo	2/934 (0.2%)		2/944 (0.2%)
Product Issues
Device Embolization	6/934 (0.6%)		2/944 (0.2%)
Device Malposition or Malfunction	1/934 (0.1%)		7/944 (0.7%)
Thrombus on Device	1/934 (0.1%)		0/944 (0%)
Psychiatric disorders
Suicide Attempt	1/934 (0.1%)		0/944 (0%)
Renal and urinary disorders
Acute Kidney Injury	8/934 (0.9%)		7/944 (0.7%)
Chronic Renal Failure	0/934 (0%)		1/944 (0.1%)
Cystitis	0/934 (0%)		1/944 (0.1%)
Hematuria	8/934 (0.9%)		8/944 (0.8%)
Nephrolithiasis	1/934 (0.1%)		0/944 (0%)
Renal Infarct	0/934 (0%)		1/944 (0.1%)
Urinary Calculi	1/934 (0.1%)		0/944 (0%)
Urinary Retention	1/934 (0.1%)		2/944 (0.2%)
Reproductive system and breast disorders
Ovarian Cyst	1/934 (0.1%)		0/944 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/934 (0.1%)		0/944 (0%)
Chronic Obstructive Pulmonary Disease (COPD)	1/934 (0.1%)		7/944 (0.7%)
Hypoxemia	1/934 (0.1%)		1/944 (0.1%)
Hypoxia	0/934 (0%)		1/944 (0.1%)
Idiopathic Interstitial Lung Diseases	1/934 (0.1%)		1/944 (0.1%)
Pleural Effusion	8/934 (0.9%)		7/944 (0.7%)
Pulmonary Embolism	9/934 (1%)		6/944 (0.6%)
Pulmonary Hypertension	0/934 (0%)		1/944 (0.1%)
Respiratory Failure	9/934 (1%)		16/944 (1.7%)
Skin and subcutaneous tissue disorders
Skin Ulcer	0/934 (0%)		1/944 (0.1%)
Surgical and medical procedures
Residual Shunt Requiring Closure	1/934 (0.1%)		1/944 (0.1%)
Surgical Closure of ASD	1/934 (0.1%)		1/944 (0.1%)
Other	1/934 (0.1%)		0/944 (0%)
Vascular disorders
Abdominal Bleeding	1/934 (0.1%)		0/944 (0%)
Arterial Hypertension/Hypertension	2/934 (0.2%)		4/944 (0.4%)
Bleeding	6/934 (0.6%)		5/944 (0.5%)
Blood Loss	2/934 (0.2%)		1/944 (0.1%)
Carotid Stenosis	4/934 (0.4%)		0/944 (0%)
Deep Vein/Venous Thrombosis	7/934 (0.7%)		5/944 (0.5%)
Epistaxis	11/934 (1.2%)		3/944 (0.3%)
Hematoma	2/934 (0.2%)		8/944 (0.8%)
Hemoptysis	2/934 (0.2%)		3/944 (0.3%)
Hypotension	6/934 (0.6%)		7/944 (0.7%)
Orthostatic Hypotension	1/934 (0.1%)		0/944 (0%)
Peripheral Arterial Occlusion	3/934 (0.3%)		0/944 (0%)
Peripheral Vascular Disease	5/934 (0.5%)		1/944 (0.1%)
Peripheral Venous Thrombus	1/934 (0.1%)		1/944 (0.1%)
Syncope	13/934 (1.4%)		16/944 (1.7%)
Systemic Embolism	2/934 (0.2%)		1/944 (0.1%)
Vascular Ischemia	1/934 (0.1%)		0/944 (0%)
Other (Not Including Serious) Adverse Events
	Amulet		WATCHMAN (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/934 (0%)		0/944 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.