REVEAL AF: Incidence of AF in High Risk Patients | NCT01727297

Label	Type	Description	Intervention Names
REVEAL Implantable Cardiac Monitor	Other		Device: REVEAL Implantable Cardiac Monitor

Name	Type	Description	Arm Group Labels	Other Names
REVEAL Implantable Cardiac Monitor	Device		REVEAL Implantable Cardiac Monitor

Measure	Description	Time Frame
18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes	Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.	Implant to 18 months post device insertion

Measure	Description	Time Frame
Predictors of the Incidence of AF	AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.	Time from implant to date of last stored available device data (maximum of 30 months)

Name	Affiliation	Role
James A Reiffel, MD	Columbia University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Heart, PLLC		Glendale	Arizona	85306-1870	United States
Cardiovascular Consultants Heart Center

PubMed Identifier	Type	Citation	Retractions
31862084	Derived	Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.
28842973

ID	Title	Description
FG000	Reveal Implantable Cardiac Monitor Implant Attempted	Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
FG001	No Reveal Implantable Cardiac Monitor Implant Attempt

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

18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes

Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.

This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.

Posted

Number

percent of participants

Implant to 18 months post device insertion

ID	Title	Description
OG000	Primary Objective Analysis Cohort	Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), who also (1) have post-implant device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal ICM implant, and (4) satisfy the Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) inclusion criteria for the study (CHADS2 score of 3 or higher, or a CHADS2 score of 2 along with chronic obstructive pulmonary disease, sleep apnea, renal impairment, or coronary artery disease)

Units	Counts
Participants	OG000385

Title

Denominators

Categories

Title	Measurements
	OG00029.3

Secondary

Predictors of the Incidence of AF

AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.

This analysis only included patients who received an implantable cardiac monitor, were not on antiarrhythmic medications at baseline, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 1 subject was on antiarrhythmic medication, and 2 subjects had no post-implant device data.

Posted

Count of Participants

Participants

Time from implant to date of last stored available device data (maximum of 30 months)

ID	Title	Description
OG000	AF Predictors Analysis Cohort: AF Episodes	Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) experienced an AF episode lasting at least 6 minutes during follow-up.
OG001	AF Predictors Analysis Cohort: No AF Episodes	Subjects successfully implanted with a Reveal Implantable Cardiac Monitor (ICM), and who (1) have post-implant ICM device data to evaluate, (2) were not on anti-arrhythmic medication at enrollment, (3) did not have AF prior to Reveal implant, and (4) did not experience an AF episode lasting at least 6 minutes during follow-up.

Secondary

Actions Taken in Response to Awareness of AF

Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized

Each visit represents the number of subjects who had a 1st, 2nd, 3rd visit, etc. in which AF was identified by the physician. Subjects in the "Sixth Visit with AF Detected" column had 6 visits in which AF was detected by the physician, and the column reflects the actions taken at that sixth visit.

Posted

Count of Units

Actions at Visits

Time from first identified episode of AF to study exit (maximum of 30 months)

Actions at Visits

ID	Title	Description
OG000	First Visit With AF Detected	Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who: Did not have diagnosed AF prior to implant, met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease), was not taking an anti-arrhythmic drug at enrollment, and Had a follow-up visit in which new AF episodes were diagnosed
OG001	Second Visit With AF Detected	Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who: Did not have diagnosed AF prior to implant, met the CHADS2 score inclusion criterion (a CHADS2 score of at least 3 or a CHADS2 score of 2 with at least one of the following: coronary artery disease, sleep apnea, renal impairment, or chronic obstructive pulmonary disease), was not taking an anti-arrhythmic drug at enrollment, and Had a 2nd follow-up visit in which new AF episodes were diagnosed

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MeDRA Preferred Term	Non-systematic Assessment	EG00015 events11 affected395 at risk EG0010 events0 affected51 at risk
Atrial fibrillation	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG00010 events10 affected395 at risk EG0010 events0 affected51 at risk
Sinus node dysfunction	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0009 events9 affected395 at risk EG0010 events0 affected51 at risk
Pneumonia	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0008 events6 affected395 at risk EG0010 events0 affected51 at risk
Transient ischaemic attack	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0008 events8 affected395 at risk EG0010 events0 affected51 at risk
Coronary artery disease	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0007 events7 affected395 at risk EG0010 events0 affected51 at risk
Acute myocardial infarction	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0006 events5 affected395 at risk EG0010 events0 affected51 at risk
Cardiac arrest	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0006 events6 affected395 at risk EG0010 events0 affected51 at risk
Cardiac failure	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0006 events3 affected395 at risk EG0010 events0 affected51 at risk
Cardiac failure congestive	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0006 events3 affected395 at risk EG0010 events0 affected51 at risk
Cerebrovascular accident	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0006 events6 affected395 at risk EG0010 events0 affected51 at risk
Bradycardia	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0005 events5 affected395 at risk EG0010 events0 affected51 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0005 events5 affected395 at risk EG0010 events0 affected51 at risk
Peripheral arterial occlusive disease	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0005 events3 affected395 at risk EG0010 events0 affected51 at risk
Peripheral vascular disorder	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0005 events4 affected395 at risk EG0010 events0 affected51 at risk
Syncope	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0005 events5 affected395 at risk EG0010 events0 affected51 at risk
Atrioventricular block complete	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0004 events4 affected395 at risk EG0010 events0 affected51 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0004 events4 affected395 at risk EG0010 events0 affected51 at risk
Hip fracture	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0004 events4 affected395 at risk EG0010 events0 affected51 at risk
Hypertensive crisis	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0004 events3 affected395 at risk EG0010 events0 affected51 at risk
Implant site pain	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0004 events4 affected395 at risk EG0010 events0 affected51 at risk
Supraventricular tachycardia	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0004 events3 affected395 at risk EG0010 events0 affected51 at risk
Angina unstable	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0003 events3 affected395 at risk EG0010 events0 affected51 at risk
Asthenia	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0003 events3 affected395 at risk EG0010 events0 affected51 at risk
Medical device site erosion	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0003 events3 affected395 at risk EG0010 events0 affected51 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0003 events3 affected395 at risk EG0010 events0 affected51 at risk
Ventricular tachycardia	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0003 events3 affected395 at risk EG0010 events0 affected51 at risk
Abdominal pain	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Acute kidney injury	Renal and urinary disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Angina pectoris	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Atrial flutter	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Atrioventricular block second degree	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0011 events1 affected51 at risk
Chronic kidney disease	Renal and urinary disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Death	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Diverticulitis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Encephalopathy	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Hypertension	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Implant site infection	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Inguinal hernia	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Orthostatic hypotension	Vascular disorders	MeDRA Preferred Term	Non-systematic Assessment	EG0002 events1 affected395 at risk EG0010 events0 affected51 at risk
Sinus bradycardia	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Small intestinal obstruction	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Ventricular extrasystoles	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0002 events2 affected395 at risk EG0010 events0 affected51 at risk
Acute coronary syndrome	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Acute prerenal failure	Renal and urinary disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Acute promyelocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Adverse drug reaction	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Aortic aneurysm	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Appendicitis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Bacteraemia	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Basal ganglia stroke	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Blood pressure increased	Investigations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Bronchitis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Cardiac failure acute	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Central nervous system inflammation	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Cerebral infarction	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Cholangitis	Hepatobiliary disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Clostridium difficile colitis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Completed suicide	Psychiatric disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Constipation	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Coronary artery occlusion	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Cystitis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Deep vein thrombosis	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Device dislocation	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Discomfort	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Dizziness	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Epilepsy	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Fall	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Gangrene	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Gastritis	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Gastroenteritis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Haemorrhage intracranial	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hepatic encephalopathy	Nervous system disorders	MeDRA Preferred Term	Non-systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hernia	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Herpes zoster	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hydronephrosis	Renal and urinary disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hypertensive encephalopathy	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hyperthyroidism	Endocrine disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hyponatraemia	Metabolism and nutrition disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Hypovolaemia	Metabolism and nutrition disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Incisional hernia	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Intestinal obstruction	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Kidney infection	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Laceration	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Lead dislodgement	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Left ventricular dysfunction	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Loss of consciousness	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Meniscus injury	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Mental status changes	Psychiatric disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Muscle strain	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Myocardial infarction	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Myocardial ischaemia	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Oesophageal obstruction	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Ovarian cyst	Reproductive system and breast disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Oversensing	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Partial seizures	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Pneumonia bacterial	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Postoperative fever	Injury, poisoning and procedural complications	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Presyncope	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Rectal polyp	Gastrointestinal disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Renal failure	Renal and urinary disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Seizure	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Sensory disturbance	Nervous system disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Sepsis	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Septic shock	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Shock	Vascular disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Sinus arrest	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Sudden death	General disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Urinary incontinence	Renal and urinary disorders	MeDRA Preferred Term	Non-systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Urinary tract infection	Infections and infestations	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Ventricular fibrillation	Cardiac disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk
Vertigo	Ear and labyrinth disorders	MeDRA Preferred Term	Systematic Assessment	EG0001 events1 affected395 at risk EG0010 events0 affected51 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Reveal Implantable Cardiac Monitor Implant Attempted	Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)	13	395	153	395	34	395
EG001	No Reveal Implantable Cardiac Monitor Implant Attempt	Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor	0	51	1	51	1	51