Amplatzer™Amulet™ Post-Market Study (Amulet™PMS) | NCT02447081

Label	Type	Description	Intervention Names
Subjects implanted with Amulet Device		All subjects who receive the Amulet device will be followed.	Device: Subjects implanted with Amulet Device

Name	Type	Description	Arm Group Labels	Other Names
Subjects implanted with Amulet Device	Device	Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.	Subjects implanted with Amulet Device

Measure	Description	Time Frame
Number of Participants With Acute Serious Adverse Events	Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure	0 to 7 days post procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure	Late adverse events were defined as those serious events with an onset date > 7 days post-procedure	7 days through 2 years
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death	Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years	Implant through 2 years
Number of Participants With Major Bleeding Events	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.	Implant through 2 years

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

Name	Affiliation	Role
David Hildick-Smith, MD	Brighton and Sussex University Hospitals	Principal Investigator
Claudio Tondo, MD PhD	University of Milan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fiona Stanley Hospital		Murdoch	Western Australia	WA 6150	Australia
Universitaire Ziekenhuizen Gasthuisberg

PubMed Identifier	Type	Citation	Retractions
34381870	Derived	De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer Amulet Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.
33762228

ID	Title	Description
FG000	Subjects Implanted With Amulet Device	Subjects implanted with Amulet Device: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 21, 2015

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Acute Serious Adverse Events

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

Posted

Count of Participants

Participants

0 to 7 days post procedure

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001088

Title

Denominators

Categories

Title	Measurements
	OG00083

Primary

Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure

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

Posted

Count of Participants

Participants

7 days through 2 years

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001088

Primary

Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death

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

Posted

Count of Participants

Participants

Implant through 2 years

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001088

Primary

Number of Participants With Major Bleeding Events

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.

Posted

Count of Participants

Participants

Implant through 2 years

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001088

Secondary

Number of Participants With Technical Success

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

Posted

Count of Participants

Participants

During implant procedure, approximately 30 to 60 minutes

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001088

Secondary

Number of Participants With Procedural Success

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

Posted

Count of Participants

Participants

During the implant procedure and hospital stay, approximately 1 or 2 days

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Oral Anti-coagulation Usage

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

Posted

Count of Participants

Participants

At discharge, approximately 1 or 2 days after the procedure

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001074

Secondary

Number of Participants With Oral Anti-coagulation Usage

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

Posted

Count of Participants

Participants

At 1 to 3 months

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001018

Secondary

Number of Participants With Oral Anti-coagulation Usage

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

Posted

Count of Participants

Participants

At 6 months

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG0001009

Secondary

Number of Participants With Oral Anti-coagulation Usage

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

Posted

Count of Participants

Participants

At 12 months

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG000950

Secondary

Number of Participants With Oral Anti-coagulation Usage

Posted

Count of Participants

Participants

At 24 months

ID	Title	Description
OG000	Subjects Implanted With Amulet Device	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.

Units	Counts
Participants	OG000864

Title	Denominators

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Acute bacterial endocarditis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Acute bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected1,088 at risk
Acute erosive gastritis	Gastrointestinal disorders		Systematic Assessment	EG0003 affected1,088 at risk
Acute kidney injury	Renal and urinary disorders		Systematic Assessment	EG0002 affected1,088 at risk
Acute pancreatitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Acute renal failure	Renal and urinary disorders		Systematic Assessment	EG00020 affected1,088 at risk
Acute subdural hematoma	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Adult respiratory distress syndrome(ARDS)	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Air embolus	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Alcohol intoxication	Injury, poisoning and procedural complications		Systematic Assessment	EG0002 affected1,088 at risk
Anemias	Blood and lymphatic system disorders		Systematic Assessment	EG00026 affected1,088 at risk
Angina pectoris	Cardiac disorders		Systematic Assessment	EG0008 affected1,088 at risk
Aortic dissection	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
Aortic value stenosis	Cardiac disorders		Systematic Assessment	EG0005 affected1,088 at risk
Aphasia	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Arm fracture	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected1,088 at risk
Arterial hypertension/Hypertension	Cardiac disorders		Systematic Assessment	EG0005 affected1,088 at risk
Ascites	Cardiac disorders		Systematic Assessment	EG0007 affected1,088 at risk
Aspiration Pneumonia/Necrotizing pneumonia/Aspiration of vomitus	Gastrointestinal disorders		Systematic Assessment	EG0004 affected1,088 at risk
Atrial fibrillation	Cardiac disorders		Systematic Assessment	EG00037 affected1,088 at risk
Atrial flutter	Cardiac disorders		Systematic Assessment	EG0008 affected1,088 at risk
Atrial tachycardia	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
Atrioventricular block	Cardiac disorders		Systematic Assessment	EG0005 affected1,088 at risk
Atrioventricular dissociation	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Back pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Bacterial infection	Infections and infestations		Systematic Assessment	EG00019 affected1,088 at risk
Bacterial infections of the skin	Infections and infestations		Systematic Assessment	EG0007 affected1,088 at risk
Benign Tumors	Gastrointestinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Bleeding	Blood and lymphatic system disorders		Systematic Assessment	EG0006 affected1,088 at risk
Bowel Obstruction	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected1,088 at risk
Brain Tumor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected1,088 at risk
Burns	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Bursitis	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG00023 affected1,088 at risk
Cardiac Arrest	Cardiac disorders		Systematic Assessment	EG00012 affected1,088 at risk
Cardiac Decompensation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected1,088 at risk
Cardiac Perforation	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Cardiogenic Shock	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Cellulitis	Infections and infestations		Systematic Assessment	EG0002 affected1,088 at risk
Cerebral Aneurysm	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Chest Pain	Cardiac disorders		Systematic Assessment	EG0007 affected1,088 at risk
Cholecystitis	Hepatobiliary disorders		Systematic Assessment	EG0002 affected1,088 at risk
Choledocholithiaisis	Hepatobiliary disorders		Systematic Assessment	EG0001 affected1,088 at risk
Cholelithiasis	Hepatobiliary disorders		Systematic Assessment	EG0004 affected1,088 at risk
Chronic Obstructive Pulmonary Disease (COPD)	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Chronic Renal Failure	General disorders		Systematic Assessment	EG0006 affected1,088 at risk
Chronic Subdural Hematoma	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Clostridum difficile Infection	Infections and infestations		Systematic Assessment	EG0004 affected1,088 at risk
Cognitive Impairment	Psychiatric disorders		Systematic Assessment	EG0001 affected1,088 at risk
Colitis	Gastrointestinal disorders		Systematic Assessment	EG0004 affected1,088 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0004 affected1,088 at risk
Compression Fracture	Injury, poisoning and procedural complications		Systematic Assessment	EG0002 affected1,088 at risk
Confusion	General disorders		Systematic Assessment	EG0004 affected1,088 at risk
Congestive Heart Failure	Cardiac disorders		Systematic Assessment	EG00013 affected1,088 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Coronary Artery Disease	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
Cutaneous Abcesses	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Cystitis	Renal and urinary disorders		Systematic Assessment	EG0001 affected1,088 at risk
Decompensated Heart Failure	Cardiac disorders		Systematic Assessment	EG00062 affected1,088 at risk
Deep Vein/Venous Thrombosis	Vascular disorders		Systematic Assessment	EG0005 affected1,088 at risk
Dehydration	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected1,088 at risk
Delirium	Psychiatric disorders		Systematic Assessment	EG0004 affected1,088 at risk
Dementia	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Device Embolization	Surgical and medical procedures		Systematic Assessment	EG0002 affected1,088 at risk
Diabetes Mellitus	Endocrine disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected1,088 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected1,088 at risk
Diverticulitis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Diverticulosis	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Dizziness	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Drug Side Effect	General disorders		Systematic Assessment	EG0001 affected1,088 at risk
Duodenal Ulcer	Gastrointestinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Dyspnea	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
EKG Abnormalities	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Elective Cardiac Surgery	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Emesis/Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Epididymitis	Infections and infestations		Systematic Assessment	EG0001 affected1,088 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Eye Bleed	Eye disorders		Systematic Assessment	EG0001 affected1,088 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0009 affected1,088 at risk
Fever	Injury, poisoning and procedural complications		Systematic Assessment	EG0004 affected1,088 at risk
Fracture	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0006 affected1,088 at risk
Fungal Skin Infection	Infections and infestations		Systematic Assessment	EG0001 affected1,088 at risk
Gastritis	Gastrointestinal disorders		Systematic Assessment	EG0004 affected1,088 at risk
Gastroenteritis	Gastrointestinal disorders		Systematic Assessment	EG0004 affected1,088 at risk
Gastrointestinal Bleeding	Gastrointestinal disorders		Systematic Assessment	EG00057 affected1,088 at risk
Gastroparesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Generalized Seizures	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Glaucoma	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Gout	General disorders		Systematic Assessment	EG0004 affected1,088 at risk
Hallucinations	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Heart Block	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Heart Failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected1,088 at risk
Heartburn	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Hematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Hematochezia	Gastrointestinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Hematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected1,088 at risk
Hematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected1,088 at risk
Hemiblock (Fascicular Block)	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Hemoperitoneum	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hemoptysis	General disorders		Systematic Assessment	EG0002 affected1,088 at risk
Hepatic and Biliary Disorders	Hepatobiliary disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hernia	Congenital, familial and genetic disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hip Dislocation	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hip Fracture	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected1,088 at risk
Hip Pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hypercalcemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hyperkalemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hypertensive Crisis	Vascular disorders		Systematic Assessment	EG0004 affected1,088 at risk
Hyperthyroidism	Endocrine disorders		Systematic Assessment	EG0002 affected1,088 at risk
Hypoglycemia	Metabolism and nutrition disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hypokalemia	General disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hypotension	Cardiac disorders		Systematic Assessment	EG0005 affected1,088 at risk
Hypothermia	General disorders		Systematic Assessment	EG0001 affected1,088 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Infective/Bacterial Endocarditis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Inguinal Hernia	Gastrointestinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Intracerebral Haemorrhage	Nervous system disorders		Systematic Assessment	EG00010 affected1,088 at risk
Iron-Deficiency Anemia	Gastrointestinal disorders		Systematic Assessment	EG0003 affected1,088 at risk
Ischemic Stroke	Cardiac disorders		Systematic Assessment	EG00039 affected1,088 at risk
Knee Pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Leukemias	Blood and lymphatic system disorders		Systematic Assessment	EG0002 affected1,088 at risk
Low Back Pain	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0003 affected1,088 at risk
Lumbar Spondylosis	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0007 affected1,088 at risk
Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0001 affected1,088 at risk
Melena	Blood and lymphatic system disorders		Systematic Assessment	EG0002 affected1,088 at risk
Miscellaneous Infections	Infections and infestations		Systematic Assessment	EG0001 affected1,088 at risk
Mitral Valve Regurgitation/Mitral Insufficiency	Cardiac disorders		Systematic Assessment	EG0005 affected1,088 at risk
Multiple Organ Failure	General disorders		Systematic Assessment	EG0004 affected1,088 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected1,088 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected1,088 at risk
Nephrolithiasis	Renal and urinary disorders		Systematic Assessment	EG0002 affected1,088 at risk
Neurological Hematoma	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Non-Cardiac Chest Pain	General disorders		Systematic Assessment	EG0002 affected1,088 at risk
Ocular Hemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Orthostatic Hypotension	Vascular disorders		Systematic Assessment	EG0001 affected1,088 at risk
Osler Weber Rendu Syndrome	Congenital, familial and genetic disorders		Systematic Assessment	EG0001 affected1,088 at risk
Osteoarthritis/Degenerative Joint Disease	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0002 affected1,088 at risk
Overdose	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Pain	General disorders		Systematic Assessment	EG0002 affected1,088 at risk
Palpitations	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Pancreatic Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0002 affected1,088 at risk
Parkinson's Disease	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Paroxysmal Atrial Tachycardia	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Perforated Appendix	Gastrointestinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Pericardial Effusion	Cardiac disorders		Systematic Assessment	EG0009 affected1,088 at risk
Pericardial Tamponade	Cardiac disorders		Systematic Assessment	EG00011 affected1,088 at risk
Peripheral Arterial Occlusion	Cardiac disorders		Systematic Assessment	EG0006 affected1,088 at risk
Peripheral Vascular Disease	Cardiac disorders		Systematic Assessment	EG0007 affected1,088 at risk
Persistent Atrial Fibrillation	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0003 affected1,088 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG00033 affected1,088 at risk
Pneumonia Caused By Gram-Negative Bacilli	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected1,088 at risk
Pneumonia in the Compromised Host	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected1,088 at risk
Polyneuropathy	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Portal-Systemic Encephalopathy	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Pressure Sores	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Presyncope	General disorders		Systematic Assessment	EG0003 affected1,088 at risk
Primary Biliary Cirrhosis	Hepatobiliary disorders		Systematic Assessment	EG0002 affected1,088 at risk
Psychogenic Event	Psychiatric disorders		Systematic Assessment	EG0001 affected1,088 at risk
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected1,088 at risk
Pulmonary Embolism	Vascular disorders		Systematic Assessment	EG0002 affected1,088 at risk
Raynaud's Syndrome	Vascular disorders		Systematic Assessment	EG0002 affected1,088 at risk
Renal Failure	General disorders		Systematic Assessment	EG0009 affected1,088 at risk
Renal Insufficiency	Renal and urinary disorders		Systematic Assessment	EG0002 affected1,088 at risk
Respiratory Failure	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected1,088 at risk
Rheumotologic Disease	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Right Ventricular Failure	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Second Degree Heart Block	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Seizure/Convulsions/Epilepsy	Nervous system disorders		Systematic Assessment	EG00014 affected1,088 at risk
Sepsis	Infections and infestations		Systematic Assessment	EG00019 affected1,088 at risk
Septicemia	Infections and infestations		Systematic Assessment	EG0002 affected1,088 at risk
Shock	General disorders		Systematic Assessment	EG0003 affected1,088 at risk
Sick Sinus Syndrome	Cardiac disorders		Systematic Assessment	EG0002 affected1,088 at risk
Simple Partial Seizures	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	Cardiac disorders		Systematic Assessment	EG0003 affected1,088 at risk
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0002 affected1,088 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders		Systematic Assessment	EG0002 affected1,088 at risk
Spinal Stenosis	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected1,088 at risk
Status Epilepticus	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected1,088 at risk
Stroke	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Subdural Haemorrhage	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Suicide Attempt	Psychiatric disorders		Systematic Assessment	EG0001 affected1,088 at risk
Sustained Atrial Fibrillation	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Syncope	General disorders		Systematic Assessment	EG00011 affected1,088 at risk
TEE-Related Event	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Third Degree Heart Block (Complete Heart Block)	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Thrombus	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Thrombus on Device	Cardiac disorders		Systematic Assessment	EG00019 affected1,088 at risk
Torsade de Pointes	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Transient Ischemic Attack (TIA)	General disorders		Systematic Assessment	EG00014 affected1,088 at risk
Trauma	General disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected1,088 at risk
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Valve	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Unstable Angina	Cardiac disorders		Systematic Assessment	EG0007 affected1,088 at risk
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Urethral Dysfunction	Renal and urinary disorders		Systematic Assessment	EG0001 affected1,088 at risk
Urinary Retention	Renal and urinary disorders		Systematic Assessment	EG0007 affected1,088 at risk
Urinary Tract Infections	Renal and urinary disorders		Systematic Assessment	EG00011 affected1,088 at risk
VASC AV Fistula	Surgical and medical procedures		Systematic Assessment	EG0004 affected1,088 at risk
VASC Bleeding	Vascular disorders		Systematic Assessment	EG0004 affected1,088 at risk
VASC Hematoma	Vascular disorders		Systematic Assessment	EG0004 affected1,088 at risk
VASC Pseudoaneurysm	Injury, poisoning and procedural complications		Systematic Assessment	EG0004 affected1,088 at risk
Vascular Dissection	Cardiac disorders		Systematic Assessment	EG0001 affected1,088 at risk
Vascular Ischemia	Cardiac disorders		Systematic Assessment	EG0003 affected1,088 at risk
Vaso Vagal Response	Nervous system disorders		Systematic Assessment	EG0001 affected1,088 at risk
Ventricular Fibrillation	Cardiac disorders		Systematic Assessment	EG0003 affected1,088 at risk
Ventricular Tachycardia	Cardiac disorders		Systematic Assessment	EG0004 affected1,088 at risk
Vessel Occlusion	Vascular disorders		Systematic Assessment	EG0001 affected1,088 at risk
Viral Syndrome	Infections and infestations		Systematic Assessment	EG0001 affected1,088 at risk
Weakness	General disorders		Systematic Assessment	EG0001 affected1,088 at risk
Wound Dehiscence	General disorders		Systematic Assessment	EG0001 affected1,088 at risk
Other	General disorders		Systematic Assessment	EG00050 affected1,088 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D001281	Atrial Fibrillation
D013923	Thromboembolism
D020521	Stroke