MitraClip NT System Post-marketing Surveillance Study - J... | NCT03500692

Name	Class
Abbott	INDUSTRY

Label	Type	Description	Intervention Names
MitraClip NT System		Percutaneous mitral valve repair using MitraClip NT System	Device: MitraClip NT System

Name	Type	Description	Arm Group Labels	Other Names
MitraClip NT System	Device	Percutaneous mitral valve repair using MitraClip NT System	MitraClip NT System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Single Leaflet Device Attachment (SLDA) Rate	SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device	up to 30 Days
No of Participants With Acute Procedural Success (APS)	APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).	up to 7 days (Discharge visit) from Procedure date

Facility	Status	City	State	ZIP	Country	Contacts
Nagoya Heart Center		Nagoya	Aichi-ken	461-0045	Japan
Toyohashi Heart Center

ID	Title	Description
FG000	MitraClip NT System	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 4, 2018	Jan 16, 2021

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG00077.92± 9.48

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
Female	BG000206
Male

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino

Region of Enrollment

Number

participants

Title

Denominators

Categories

Japan

- ParticipantsBG000500

Title	Measurements
	BG000500

Height

Mean

Standard Deviation

Centimeters

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG000156.96± 10.02

Weight

Mean

Standard Deviation

Kilograms

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG00052.05± 10.68

Body Mass Index

Mean

Standard Deviation

Kg/m^2

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG00021.01± 3.22

Society of Thoracic Surgeons (STS) Score

The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. As of November 15, 2018, The Society of Thoracic Surgeons released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries.

Mean

Standard Deviation

Percentage of Expected Mortality

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG000

Cardiovascular History

All available data has been presented.

Count of Participants

Participants

Title

Denominators

Categories

Dyslipidemia

- ParticipantsBG000498

Title	Measurements
	BG000216

Cardiac Intervention History

All available data has been reported.

Count of Participants

Participants

Title

Denominators

Categories

Prior Cardiac Surgeries

- ParticipantsBG000500

Title	Measurements
	BG00089

Co-Morbidity

All available data has been reported

Count of Participants

Participants

Title

Denominators

Categories

Currently Smoking

- ParticipantsBG000492

Title	Measurements
	BG00030

Heart Valve Intervention

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG000500

Title	Measurements
	BG00028

Prior Heart Failure Hospitalization Within 1 year

All available data has been reported.

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG000499

Title	Measurements
	BG000321

Baseline Etiology of Mitral Regurgitation

Count of Participants

Participants

Title

Denominators

Categories

Degenerative MR Only

- ParticipantsBG000500

Title	Measurements
	BG000126

Functional MR Only

Baseline Effective Regurgitant Orifice Area

Effective regurgitant orifice area is an important and clinically significant index of regurgitation severity. Effective regurgitant orifice area is calculated by Doppler echocardiography as the ratio of regurgitant volume/regurgitant jet time-velocity integral.

Data was not available for all the subjects.

Mean

Standard Deviation

cm^2

Title

Denominators

Categories

- ParticipantsBG000460

Title	Measurements
	BG000

Regurgitant Volume

Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

Data was not available for all the subjects.

Mean

Standard Deviation

mL/beat

Title

Denominators

Categories

- ParticipantsBG000461

Title	Measurements
	BG000

Left Ventricular Ejection Fraction (LVEF)

All available data has been reported.

Mean

Standard Deviation

Percentage Of Ejection Fraction

Title

Denominators

Categories

- ParticipantsBG000499

Title	Measurements
	BG000

Left Ventricular End Systolic Volume (LVESV)

Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

All available data has been reported.

Mean

Standard Deviation

Title

Denominators

Categories

- ParticipantsBG000458

Title	Measurements
	BG000

Left Ventricular End Diastolic Volume (LVEDV)

Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

All available data has been reported.

Mean

Standard Deviation

Title

Denominators

Categories

- ParticipantsBG000451

Title	Measurements
	BG000

Serum Creatinine

All available data has been reported.

Mean

Standard Deviation

mg/dl

Title

Denominators

Categories

- ParticipantsBG000498

Title	Measurements
	BG0001.71± 1.54

Brain Natriuretic Peptide (BNP)

All available data has been reported

Mean

Standard Deviation

pg/mL

Title

Denominators

Categories

- ParticipantsBG000407

Title	Measurements
	BG000567.11

N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)

All available data has been reported

Mean

Standard Deviation

Pg/mL

Title

Denominators

Categories

- ParticipantsBG000173

Title	Measurements
	BG000

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

Single Leaflet Device Attachment (SLDA) Rate

SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device

All subjects with available data were included for analysis.

Posted

Number

percentage of SLDAs

up to 30 Days

ID	Title	Description
OG000	MitraClip NT System	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System

Units	Counts
Participants	OG000497

Title

Denominators

Categories

Title	Measurements
	OG0001.21

Primary

No of Participants With Acute Procedural Success (APS)

APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment.

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

All subjects with available data were used for analysis.

Posted

Count of Participants

Participants

up to 7 days (Discharge visit) from Procedure date

ID	Title	Description
OG000	MitraClip NT System	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected500 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Angina Pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Angina Unstable	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Arrhythmia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00017 events12 affected500 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Atrial Thrombosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Cardiac Failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG000241 events142 affected500 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Chordae Tendinae Rupture	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Intracardiac Thrombus	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00024 events24 affected500 at risk
Mitral Valve Prolapse	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0009 events9 affected500 at risk
Mitral Valve Stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected500 at risk
Sinus Arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Tricuspid Valve Incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events4 affected500 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00017 events13 affected500 at risk
Atrial Septal Defect	Congenital, familial and genetic disorders	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected500 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Basedow's Disease	Endocrine disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cataract	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected500 at risk
Glaucoma	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Breath Odour	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Ileus	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Oesophageal Perforation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG00029 events29 affected500 at risk
Multi-Organ Failure	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Sudden Cardiac Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Cholangitis Acute	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Appendicitis Perforated	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Bacteraemia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Bronchopneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Endocarditis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Herpes Zoster	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Meningitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00021 events20 affected500 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Psoas Abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pyelonephritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0008 events8 affected500 at risk
Septic Shock	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Compression Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected500 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0005 events5 affected500 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Spinal Cord Injury Cervical	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Vascular Access Complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Venous Injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected500 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected500 at risk
Gallbladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected500 at risk
Hepatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected500 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Hypoglycaemic Coma	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Intracranial Aneurysm	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00010 events9 affected500 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Azotaemia	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Renal Failure	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG00025 events25 affected500 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected500 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events4 affected500 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected500 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00014 events13 affected500 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Henoch-Schonlein Purpura	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cardiac Pacemaker Replacement	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Haemodialysis	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Aortic Dissection	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Arteriosclerosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Embolism	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00019 events19 affected500 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events2 affected500 at risk
Peripheral Embolism	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Ventricular Dyssynchrony	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Enteritis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Gastrointestinal Perforation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events1 affected500 at risk
Device Battery Issue	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Device Deployment Issue	General disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Device Power Source Issue	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Hernia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Implant Site Haemorrhage	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pyrexia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Sudden Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cellulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Device Related Sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Tooth Abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Heat Stroke	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
International Normalised Ratio Increased	Investigations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Carcinoma In Situ Of Eye	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Encephalitis	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Epilepsy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected500 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Central Venous Catheterisation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Implantable Defibrillator Insertion	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Leg Amputation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Aortic Stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Aortic Valve Disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Bradycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Cardiac Failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Chordae Tendinae Rupture	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected500 at risk
Mitral Valve Prolapse	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Mitral Valve Stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0005 events4 affected500 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Atrial Septal Defect	Congenital, familial and genetic disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Influenza	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Peripheral Artery Aneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected500 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk
Device Deployment Issue	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected500 at risk

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases