Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02447081
• Collaborator: (none)
• Enrollment: 1,088
• Locations: 51
• Actual Duration (Months): 40.7
• Patients Per Site: 21.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Thromboembolism; Stroke	Device: Subjects implanted with Amulet Device

Detailed Description

A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.

The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.

Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 1088 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Amplatzer™Amulet™ Observational Post-Market Study
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 23, 2018
• Actual Study Completion Date: Oct 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Subjects implanted with Amulet Device All subjects who receive the Amulet device will be followed.	Device: Subjects implanted with Amulet Device; Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Acute Serious Adverse Events [0 to 7 days post procedure]

   Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure

2. Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure [7 days through 2 years]

   Late adverse events were defined as those serious events with an onset date > 7 days post-procedure

3. Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death [Implant through 2 years]

   Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years

4. Number of Participants With Major Bleeding Events [Implant through 2 years]

   Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.

Secondary Outcome Measures

1. Number of Participants With Technical Success [During implant procedure, approximately 30 to 60 minutes]

   Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).

2. Number of Participants With Procedural Success [During the implant procedure and hospital stay, approximately 1 or 2 days]

   Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event

3. Number of Participants With Oral Anti-coagulation Usage [At discharge, approximately 1 or 2 days after the procedure]

4. Number of Participants With Oral Anti-coagulation Usage [At 1 to 3 months]

5. Number of Participants With Oral Anti-coagulation Usage [At 6 months]

6. Number of Participants With Oral Anti-coagulation Usage [At 12 months]

7. Number of Participants With Oral Anti-coagulation Usage [At 24 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subject with history of paroxysmal, persistent or permanent NVAF

2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law

3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion

4. Subject who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria:

1. Subject with evidence of an intracardiac thrombus

2. Subject with active infection or active endocarditis or other infections producing bacteremia

3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures

4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results

5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)

6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	WA 6150
2	Universitaire Ziekenhuizen Gasthuisberg	Leuven		Belgium
3	Hospital Clinico San Borja Arriaran	Santiago		Chile	83600160
4	Rigshospitalet	Copenhagen		Denmark	2100
5	Helsinki University Central Hospital	Helsinki	Uusimaa	Finland
6	Turku University Hospital	Turku		Finland
7	Hopital Haut Leveque	Pessac	Aquitaine	France	33600
8	CHU du Bocage	Dijon	Burgundy	France	21034
9	CHRU Lille	Lille	North-Calais	France	59037
10	CHU d'Amiens	Amiens	Picardy	France	80054
11	Klinikum Coburg	Coburg	Bavaria	Germany	96450
12	Internistische Klinik Dr. Müller, München-Thalkirchen	Muenchen	Bavaria	Germany	81379
13	Universitaetsklinikum Ulm	Ulm	Bavaria	Germany	89081
14	Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt	Darmstadt	Hesse	Germany	64287
15	CardioVaskuläres Centrum St. Katharinen	Frankfurt	Hesse	Germany	60389
16	Universitätsklinikum Düsseldorf	Duesseldorf	North Rhine-Westphal	Germany	40225
17	Zentralklinik Bad Berka Gmbh	Bad Berka	Thuringia	Germany	99437
18	Zentralklinik Bad Berka	Bad Berka		Germany
19	Segeberger Kliniken Gmbh	Bad Segeberg		Germany	23795
20	Segeberger Kliniken GmbH	Bad Segeberg		Germany
21	Charité - Universitätsmedizin Berlin (CBF)	Berlin		Germany	12203
22	St. Marien Hospital Bonn	Bonn		Germany	53115
23	Herzzentrum Dresden	Dresden		Germany
24	Cardioangiologisches Centrum Bethanien	Frankfurt		Germany	60431
25	Klinikum Frankfurt Höchst	Frankfurt		Germany	65929
26	Harzklinikum Dorothea Christiane Erxleben GmbH	Quedlinburg		Germany
27	Rems-Murr-Klinikum Winnenden	Winnenden		Germany	71364
28	Mater Hospital	Dublin		Ireland
29	The Chaim Sheba Medical Center	Tel Hashomer		Israel	52621
30	Nuovo Ospedale Civile Sant'Agostino Estense	Baggiovara, 1355	Modena	Italy	41126
31	Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia	Mestre	Veneto	Italy	30174
32	Università degli Studi di Padova	Padova	Veneto	Italy	35128
33	Azienda Ospedaliera S. Anna e S. Sebastiano	Caserta		Italy	81100
34	Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio	Massa		Italy
35	Ospedale Luigi Sacco	Milano		Italy	20157
36	Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan	Milan		Italy
37	San Raffaele Hospital	Milan		Italy
38	Amsterdam Academic Medical Centre	Veenendaal		Netherlands
39	Ulleval Universitetssykehus	Oslo		Norway	0407
40	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw		Poland	04-628
41	Slaskie Centrum Chorob Serca	Warszawa		Poland	01-785
42	Hospital Universitario Virgen Macarena	Sevilla	Andalusia	Spain	41007
43	Hospital Universitario Son Espases	Palma de Mallorca	Balearic Island	Spain	07120
44	Hospital Universitario de Salamanca	Salamanca	Castile And Leon	Spain	37007
45	Hospital de la Santa Creu I Sant Pau	Barcelona	Catalonia	Spain	08025
46	Hospital Universitario Infanta Cristina	Badajoz	Extremadura	Spain	6080
47	Hospital Clinic I Provincial de Barcelona	Barcelona		Spain	8028
48	Karolinska University Hospital Huddinge	Stockholm		Sweden	17176
49	Liverpool Heart and Chest Hospital	Liverpool	Northwest England	United Kingdom
50	The Royal Sussex Country Hospital	Brighton	South East England	United Kingdom
51	St Thomas Hospital	London		United Kingdom	SE1 7EH

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: David Hildick-Smith, MD, Brighton and Sussex University Hospitals
• Principal Investigator: Claudio Tondo, MD PhD, University of Milan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 21, 2015

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02447081
• Other Study ID Numbers: SJM-CIP-10053
• First Posted: May 18, 2015
• Last Update Posted: Dec 30, 2019
• Last Verified: Dec 1, 2019

• Additional relevant MeSH terms: Atrial Fibrillation; Thromboembolism

Study Results

Participant Flow

Recruitment Details	A total of 1088 subjects were enrolled and attempted implant with Amulet left atrial appendage occluder conducted at 61 sites between June 01, 2015 and September 19, 2016. The final study visit at 2 years post-implant was completed by 864 subjects, with the last study visit occurring in October 2018.

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Period Title: Overall Study
STARTED	1088
COMPLETED	864
NOT COMPLETED	224

Baseline Characteristics

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Overall Participants	1088
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	122 11.2%
>=65 years	966 88.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.2 (8.5)
Sex: Female, Male (Count of Participants)
Female	386 35.5%
Male	702 64.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	59 5.4%
Spain	105 9.7%
Netherlands	1 0.1%
Sweden	13 1.2%
Belgium	17 1.6%
Norway	5 0.5%
Finland	55 5.1%
Poland	26 2.4%
Denmark	62 5.7%
Italy	178 16.4%
Israel	1 0.1%
Australia	70 6.4%
France	65 6%
Chile	6 0.6%
Germany	378 34.7%
Hong Kong	41 3.8%
Switzerland	6 0.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Acute Serious Adverse Events
Description	Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Time Frame	0 to 7 days post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	83 7.6%

2. Primary Outcome

Title	Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Description	Late adverse events were defined as those serious events with an onset date > 7 days post-procedure
Time Frame	7 days through 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	504 46.3%

3. Primary Outcome

Title	Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Description	Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Time Frame	Implant through 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	122 11.2%

4. Primary Outcome

Title	Number of Participants With Major Bleeding Events
Description	Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
Time Frame	Implant through 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	110 10.1%

5. Secondary Outcome

Title	Number of Participants With Technical Success
Description	Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
Time Frame	During implant procedure, approximately 30 to 60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	1078 99.1%

6. Secondary Outcome

Title	Number of Participants With Procedural Success
Description	Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
Time Frame	During the implant procedure and hospital stay, approximately 1 or 2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1088
Count of Participants [Participants]	1039 95.5%

7. Secondary Outcome

Title	Number of Participants With Oral Anti-coagulation Usage
Time Frame	At discharge, approximately 1 or 2 days after the procedure

Outcome Measure Data

Analysis Population Description

The number of participates completing a study visit at the Time Frame

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1074
OAC without anti-platelet therapy	49 4.5%
OAC with antiplatelet therapy	71 6.5%

8. Secondary Outcome

Title	Number of Participants With Oral Anti-coagulation Usage
Time Frame	At 1 to 3 months

Outcome Measure Data

Analysis Population Description

The number of participates completing a study visit at the Time Frame

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1018
OAC without anti-platelet therapy	29 2.7%
OAC with anti-platelet therapy	34 3.1%

9. Secondary Outcome

Title	Number of Participants With Oral Anti-coagulation Usage
Time Frame	At 6 months

Outcome Measure Data

Analysis Population Description

The number of participates completing a study visit at the Time Frame

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	1009
OAC without anti-platelet therapy	33 3%
OAC with anti-platelet therapy	23 2.1%

10. Secondary Outcome

Title	Number of Participants With Oral Anti-coagulation Usage
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

The number of participates completing a study visit at the Time Frame

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	950
OAC without anti-platelet therapy	35 3.2%
OAC with anti-platelet therapy	21 1.9%

11. Secondary Outcome

Title	Number of Participants With Oral Anti-coagulation Usage
Time Frame	At 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Measure Participants	864
OAC without anti-platelet therapy	38 3.5%
OAC with anti-platelet therapy	19 1.7%

Adverse Events

Time Frame	2 years
Adverse Event Reporting Description	Non-serious adverse event information was not analyzed.
Arm/Group Title	Subjects Implanted With Amulet Device
Arm/Group Description	All subjects who received the Amulet device were followed. Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
All Cause Mortality
	Subjects Implanted With Amulet Device
	Affected / at Risk (%)	# Events
Total	161/1088 (14.8%)
Serious Adverse Events
	Subjects Implanted With Amulet Device
	Affected / at Risk (%)	# Events
Total	538/1088 (49.4%)
Blood and lymphatic system disorders
Anemias	26/1088 (2.4%)
Bleeding	6/1088 (0.6%)
Leukemias	2/1088 (0.2%)
Melena	2/1088 (0.2%)
Cardiac disorders
Acute bacterial endocarditis	1/1088 (0.1%)
Angina pectoris	8/1088 (0.7%)
Aortic dissection	2/1088 (0.2%)
Aortic value stenosis	5/1088 (0.5%)
Arterial hypertension/Hypertension	5/1088 (0.5%)
Ascites	7/1088 (0.6%)
Atrial fibrillation	37/1088 (3.4%)
Atrial flutter	8/1088 (0.7%)
Atrial tachycardia	2/1088 (0.2%)
Atrioventricular block	5/1088 (0.5%)
Atrioventricular dissociation	1/1088 (0.1%)
Cardiac Arrest	12/1088 (1.1%)
Cardiac Decompensation	15/1088 (1.4%)
Cardiac Perforation	1/1088 (0.1%)
Cardiogenic Shock	1/1088 (0.1%)
Chest Pain	7/1088 (0.6%)
Congestive Heart Failure	13/1088 (1.2%)
Coronary Artery Disease	2/1088 (0.2%)
Decompensated Heart Failure	62/1088 (5.7%)
Dyspnea	2/1088 (0.2%)
EKG Abnormalities	1/1088 (0.1%)
Heart Block	1/1088 (0.1%)
Heart Failure	6/1088 (0.6%)
Hemiblock (Fascicular Block)	1/1088 (0.1%)
Hypotension	5/1088 (0.5%)
Ischemic Stroke	39/1088 (3.6%)
Mitral Valve Regurgitation/Mitral Insufficiency	5/1088 (0.5%)
Myocardial Infarction	10/1088 (0.9%)
Overdose	1/1088 (0.1%)
Palpitations	1/1088 (0.1%)
Paroxysmal Atrial Tachycardia	1/1088 (0.1%)
Pericardial Effusion	9/1088 (0.8%)
Pericardial Tamponade	11/1088 (1%)
Peripheral Arterial Occlusion	6/1088 (0.6%)
Peripheral Vascular Disease	7/1088 (0.6%)
Persistent Atrial Fibrillation	2/1088 (0.2%)
Right Ventricular Failure	1/1088 (0.1%)
Second Degree Heart Block	1/1088 (0.1%)
Sick Sinus Syndrome	2/1088 (0.2%)
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	3/1088 (0.3%)
Sustained Atrial Fibrillation	1/1088 (0.1%)
TEE-Related Event	1/1088 (0.1%)
Third Degree Heart Block (Complete Heart Block)	1/1088 (0.1%)
Thrombus	1/1088 (0.1%)
Thrombus on Device	19/1088 (1.7%)
Torsade de Pointes	1/1088 (0.1%)
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Valve	1/1088 (0.1%)
Unstable Angina	7/1088 (0.6%)
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia	1/1088 (0.1%)
Vascular Dissection	1/1088 (0.1%)
Vascular Ischemia	3/1088 (0.3%)
Ventricular Fibrillation	3/1088 (0.3%)
Ventricular Tachycardia	4/1088 (0.4%)
Congenital, familial and genetic disorders
Hernia	1/1088 (0.1%)
Osler Weber Rendu Syndrome	1/1088 (0.1%)
Endocrine disorders
Diabetes Mellitus	2/1088 (0.2%)
Hyperthyroidism	2/1088 (0.2%)
Eye disorders
Eye Bleed	1/1088 (0.1%)
Glaucoma	1/1088 (0.1%)
Ocular Hemorrhage	1/1088 (0.1%)
Gastrointestinal disorders
Abdominal Pain	2/1088 (0.2%)
Acute erosive gastritis	3/1088 (0.3%)
Acute pancreatitis	1/1088 (0.1%)
Aspiration Pneumonia/Necrotizing pneumonia/Aspiration of vomitus	4/1088 (0.4%)
Benign Tumors	2/1088 (0.2%)
Bowel Obstruction	2/1088 (0.2%)
Colitis	4/1088 (0.4%)
Constipation	1/1088 (0.1%)
Diarrhea	5/1088 (0.5%)
Diverticulitis	1/1088 (0.1%)
Diverticulosis	1/1088 (0.1%)
Duodenal Ulcer	2/1088 (0.2%)
Emesis/Vomiting	1/1088 (0.1%)
Gastritis	4/1088 (0.4%)
Gastroenteritis	4/1088 (0.4%)
Gastrointestinal Bleeding	57/1088 (5.2%)
Gastroparesis	1/1088 (0.1%)
Heartburn	1/1088 (0.1%)
Hematemesis	1/1088 (0.1%)
Hematochezia	2/1088 (0.2%)
Hemoperitoneum	1/1088 (0.1%)
Inguinal Hernia	2/1088 (0.2%)
Iron-Deficiency Anemia	3/1088 (0.3%)
Perforated Appendix	1/1088 (0.1%)
General disorders
Chronic Renal Failure	6/1088 (0.6%)
Confusion	4/1088 (0.4%)
Drug Side Effect	1/1088 (0.1%)
Gout	4/1088 (0.4%)
Hemoptysis	2/1088 (0.2%)
Hypokalemia	1/1088 (0.1%)
Hypothermia	1/1088 (0.1%)
Multiple Organ Failure	4/1088 (0.4%)
Non-Cardiac Chest Pain	2/1088 (0.2%)
Pain	2/1088 (0.2%)
Presyncope	3/1088 (0.3%)
Renal Failure	9/1088 (0.8%)
Shock	3/1088 (0.3%)
Syncope	11/1088 (1%)
Transient Ischemic Attack (TIA)	14/1088 (1.3%)
Trauma	9/1088 (0.8%)
Weakness	1/1088 (0.1%)
Wound Dehiscence	1/1088 (0.1%)
Other	50/1088 (4.6%)
Hepatobiliary disorders
Cholecystitis	2/1088 (0.2%)
Choledocholithiaisis	1/1088 (0.1%)
Cholelithiasis	4/1088 (0.4%)
Hepatic and Biliary Disorders	1/1088 (0.1%)
Primary Biliary Cirrhosis	2/1088 (0.2%)
Infections and infestations
Bacterial infection	19/1088 (1.7%)
Bacterial infections of the skin	7/1088 (0.6%)
Cellulitis	2/1088 (0.2%)
Clostridum difficile Infection	4/1088 (0.4%)
Epididymitis	1/1088 (0.1%)
Fungal Skin Infection	1/1088 (0.1%)
Infective/Bacterial Endocarditis	1/1088 (0.1%)
Miscellaneous Infections	1/1088 (0.1%)
Sepsis	19/1088 (1.7%)
Septicemia	2/1088 (0.2%)
Viral Syndrome	1/1088 (0.1%)
Injury, poisoning and procedural complications
Alcohol intoxication	2/1088 (0.2%)
Burns	1/1088 (0.1%)
Compression Fracture	2/1088 (0.2%)
Fall	9/1088 (0.8%)
Fever	4/1088 (0.4%)
Respiratory Failure	1/1088 (0.1%)
VASC Pseudoaneurysm	4/1088 (0.4%)
Metabolism and nutrition disorders
Dehydration	1/1088 (0.1%)
Hypercalcemia	1/1088 (0.1%)
Hyperkalemia	1/1088 (0.1%)
Hypoglycemia	1/1088 (0.1%)
Musculoskeletal and connective tissue disorders
Arm fracture	2/1088 (0.2%)
Back pain	1/1088 (0.1%)
Bursitis	1/1088 (0.1%)
Fracture	6/1088 (0.6%)
Hip Dislocation	1/1088 (0.1%)
Hip Fracture	7/1088 (0.6%)
Hip Pain	1/1088 (0.1%)
Knee Pain	1/1088 (0.1%)
Low Back Pain	3/1088 (0.3%)
Lumbar Spondylosis	1/1088 (0.1%)
Musculoskeletal Pain	3/1088 (0.3%)
Osteoarthritis/Degenerative Joint Disease	2/1088 (0.2%)
Rheumotologic Disease	1/1088 (0.1%)
Spinal Stenosis	1/1088 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/1088 (0.1%)
Cancer	23/1088 (2.1%)
Colon Cancer	4/1088 (0.4%)
Lung Cancer	7/1088 (0.6%)
Melanoma	1/1088 (0.1%)
Pancreatic Cancer	2/1088 (0.2%)
Skin Cancer	2/1088 (0.2%)
Nervous system disorders
Acute subdural hematoma	1/1088 (0.1%)
Aphasia	1/1088 (0.1%)
Brain Tumor	1/1088 (0.1%)
Cerebral Aneurysm	1/1088 (0.1%)
Chronic Subdural Hematoma	1/1088 (0.1%)
Dementia	1/1088 (0.1%)
Dizziness	1/1088 (0.1%)
Encephalopathy	1/1088 (0.1%)
Generalized Seizures	1/1088 (0.1%)
Intracerebral Haemorrhage	10/1088 (0.9%)
Neurological Hematoma	1/1088 (0.1%)
Parkinson's Disease	1/1088 (0.1%)
Polyneuropathy	1/1088 (0.1%)
Portal-Systemic Encephalopathy	1/1088 (0.1%)
Seizure/Convulsions/Epilepsy	14/1088 (1.3%)
Simple Partial Seizures	1/1088 (0.1%)
Status Epilepticus	1/1088 (0.1%)
Stroke	1/1088 (0.1%)
Subdural Haemorrhage	1/1088 (0.1%)
Vaso Vagal Response	1/1088 (0.1%)
Psychiatric disorders
Cognitive Impairment	1/1088 (0.1%)
Delirium	4/1088 (0.4%)
Hallucinations	1/1088 (0.1%)
Psychogenic Event	1/1088 (0.1%)
Suicide Attempt	1/1088 (0.1%)
Renal and urinary disorders
Acute kidney injury	2/1088 (0.2%)
Acute renal failure	20/1088 (1.8%)
Cystitis	1/1088 (0.1%)
Hematuria	12/1088 (1.1%)
Nephrolithiasis	2/1088 (0.2%)
Renal Insufficiency	2/1088 (0.2%)
Urethral Dysfunction	1/1088 (0.1%)
Urinary Retention	7/1088 (0.6%)
Urinary Tract Infections	11/1088 (1%)
Respiratory, thoracic and mediastinal disorders
Acute bronchitis	5/1088 (0.5%)
Acute pulmonary edema	2/1088 (0.2%)
Adult respiratory distress syndrome(ARDS)	1/1088 (0.1%)
Air embolus	1/1088 (0.1%)
Bronchitis	2/1088 (0.2%)
Chronic Obstructive Pulmonary Disease (COPD)	2/1088 (0.2%)
Epistaxis	2/1088 (0.2%)
Hypoventilation	1/1088 (0.1%)
Pleural Effusion	3/1088 (0.3%)
Pneumonia	33/1088 (3%)
Pneumonia Caused By Gram-Negative Bacilli	2/1088 (0.2%)
Pneumonia in the Compromised Host	2/1088 (0.2%)
Pulmonary Edema	1/1088 (0.1%)
Skin and subcutaneous tissue disorders
Cutaneous Abcesses	1/1088 (0.1%)
Pressure Sores	1/1088 (0.1%)
Skin Ulcer	2/1088 (0.2%)
Surgical and medical procedures
Device Embolization	2/1088 (0.2%)
Elective Cardiac Surgery	1/1088 (0.1%)
VASC AV Fistula	4/1088 (0.4%)
Vascular disorders
Deep Vein/Venous Thrombosis	5/1088 (0.5%)
Hematoma	5/1088 (0.5%)
Hypertensive Crisis	4/1088 (0.4%)
Orthostatic Hypotension	1/1088 (0.1%)
Pulmonary Embolism	2/1088 (0.2%)
Raynaud's Syndrome	2/1088 (0.2%)
VASC Bleeding	4/1088 (0.4%)
VASC Hematoma	4/1088 (0.4%)
Vessel Occlusion	1/1088 (0.1%)
Other (Not Including Serious) Adverse Events
	Subjects Implanted With Amulet Device
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.