Study of Continuous Cardiac Monitoring to Assess Atrial F... | NCT00924638

Label	Type	Description	Intervention Names
Continuous Monitoring	Active Comparator	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor	Device: Reveal® XT Insertable Cardiac Monitor
Control Arm	No Intervention	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Name	Type	Description	Arm Group Labels	Other Names
Reveal® XT Insertable Cardiac Monitor	Device	The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.

Measure	Description	Time Frame
AF Detection Rate Within 6 Months	Percentage of subjects with AF detected within 6 months of follow-up	6 months

Measure	Description	Time Frame
AF Detection Rate Within 12 Months	Percentage of subjects with AF detected within 12 months of follow-up	12 months
Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)	Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up

Name	Affiliation	Role
Johannes Brachmann, MD	Klinikum Coburg, Germany	Principal Investigator
Tommaso Sanna, MD	Catholic University, Italy	Principal Investigator
Hans Christoph Diener, MD	Klinik für Neurologie, Essen, Germany	Principal Investigator
Carlos Morillo, MD	McMaster Clinic, Hamilton, Ontario, Canada	Principal Investigator
Richard Bernstein, MD, PhD	Davee Department of Neurology, Chicago, IL USA	Principal Investigator
Vincenzo Di Lazzaro, MD	Catholic University Rome, Rome Italy	Principal Investigator
Rod Passman, MD	Northwestern Memorial Hospital, Chicago, IL USA	Principal Investigator
Marilyn Rymer, MD	St. Lukes Hospital of Kansas City, Kansas City, MI USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
El Camino Hospital		Mountain View	California		United States
South Denver Cardiology / Swedish Medical Center

PubMed Identifier	Type	Citation	Retractions
16432246	Background	Sacco RL, Adams R, Albers G, Alberts MJ, Benavente O, Furie K, Goldstein LB, Gorelick P, Halperin J, Harbaugh R, Johnston SC, Katzan I, Kelly-Hayes M, Kenton EJ, Marks M, Schwamm LH, Tomsick T; American Heart Association; American Stroke Association Council on Stroke; Council on Cardiovascular Radiology and Intervention; American Academy of Neurology. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: the American Academy of Neurology affirms the value of this guideline. Stroke. 2006 Feb;37(2):577-617. doi: 10.1161/01.STR.0000199147.30016.74.
20598970

ID	Title	Description
FG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.

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

AF Detection Rate Within 6 Months

Percentage of subjects with AF detected within 6 months of follow-up

Intention-to-treat (ITT) population (all randomized subjects)

Posted

Number

percentage of participants

6 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000221 OG001220

Title

Denominators

Categories

Title	Measurements
	OG0008.9 OG0011.4

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.0006		Hazard Ratio (HR)	6.4			2-Sided	95	1.9	21.7			A hazard ratio of > 1 indicates that Continuous Monitoring is superior to Control in detecting AF.	No	Superiority or Other

Secondary

AF Detection Rate Within 12 Months

Percentage of subjects with AF detected within 12 months of follow-up

Intention-to-treat (ITT) population (all randomized subjects)

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)

Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up

Intention-to-treat (ITT) population (all randomized subjects)

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Use of Oral Anticoagulation (OAC) Drugs

Percentage of subjects who were using OAC drugs at the 12 months follow-up visit

Number of subjects who completed the 12-months follow-up visit

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Use of Antiarrhythmic Drugs

Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit

Number of subjects who completed the 12 months follow-up visit

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Health Outcome as Evaluated by EQ-5D Questionnaire

EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).

Number of subjects who reported EQ-5D VAS score at the 12 months visit

Posted

Mean

Standard Deviation

units on a scale of 0 to 100

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Clinical Disease Burden and Care Pathway

Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months

Intention-to-treat (ITT) population (all randomized subjects)

Posted

Number

percentage of participants

12 months

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
OG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Units	Counts
Participants	OG000

Secondary

Impact of Patient Assistant Use on AF Diagnosis

AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency

Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study

Posted

Mean

Standard Deviation

days from AF occurrence to AF diagnosis

Follow-up closure

ID	Title	Description
OG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Adverse drug reaction	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Angina unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Aphasia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0006 events6 affected221 at risk EG0013 events3 affected220 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected221 at risk EG0015 events5 affected220 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events2 affected220 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00012 events11 affected221 at risk EG0015 events5 affected220 at risk
Cerebrovascular spasm	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0005 events5 affected221 at risk EG0010 events0 affected220 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Chondrolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 events1 affected221 at risk EG0010 events0 affected220 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 events2 affected221 at risk EG0012 events2 affected220 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected221 at risk EG0010 events0 affected220 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Dysarthria	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Dysuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Enteritis infectious	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Epilepsy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0012 events2 affected220 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0011 events1 affected220 at risk
Gait disturbance	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0011 events1 affected220 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected220 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected221 at risk EG0010 events0 affected220 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events2 affected220 at risk
Implant site infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected221 at risk EG0011 events1 affected220 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Macular degeneration	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Medical device removal	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Mental status changes	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Migraine	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected220 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected220 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Nephropathy	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0002 events1 affected221 at risk EG0010 events0 affected220 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 events2 affected221 at risk EG0012 events2 affected220 at risk
Pocket erosion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0012 events2 affected220 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Retinal artery embolism	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Retinal artery occlusion	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected220 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected221 at risk EG0010 events0 affected220 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0011 events1 affected220 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Somatisation disorder	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Sudden death	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Tension headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0006 events6 affected221 at risk EG0019 events9 affected220 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Urethral disorder	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Urosepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected221 at risk EG0010 events0 affected220 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected221 at risk EG0010 events0 affected220 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected221 at risk EG0011 events1 affected220 at risk

ID	Term
D000083242	Ischemic Stroke
D001281	Atrial Fibrillation

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
BG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Continuous Monitoring	Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.			68	221	41	221
EG001	Control Arm	Follow-up at the same frequency, but with no Insertable Cardiac Monitor			58	220	9	220