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REVEAL AF: Incidence of AF in High Risk Patients

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ClinicalTrials.gov Identifier: NCT01727297
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : March 29, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Atrial Fibrillation
Intervention Device: REVEAL Implantable Cardiac Monitor
Enrollment 446
Recruitment Details  
Pre-assignment Details Patients in the 'No Reveal Implantable Cardiac Monitor Implant Attempt' arm were exited from the study prior to an implant attempt. Therefore, no outcome data are available. Baseline data are not presented due to variable data collection before the time of exit. Adverse event data were collected for this cohort, and are reported below.
Arm/Group Title Reveal Implantable Cardiac Monitor Implant Attempted No Reveal Implantable Cardiac Monitor Implant Attempt
Hide Arm/Group Description Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted) Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
Period Title: Overall Study
Started 395 51
Completed 293 0
Not Completed 102 51
Reason Not Completed
Death             13             0
Protocol Violation             1             10
Adverse Event             3             1
Lost to Follow-up             11             0
Withdrawal by Subject             26             27
Physician Decision             19             5
Other (e.g. AF detection pre-implant)             29             8
Arm/Group Title Reveal Implantable Cardiac Monitor Implant Attempted
Hide Arm/Group Description Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
Overall Number of Baseline Participants 395
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants
<=18 years
0
   0.0%
Between 18 and 65 years
88
  22.3%
>=65 years
307
  77.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 395 participants
71.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants
Female
188
  47.6%
Male
207
  52.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 395 participants
Austria 18
Netherlands 6
United States 302
Italy 19
Slovenia 4
Germany 39
Spain 7
1.Primary Outcome
Title 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
Hide Description 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.
Time Frame Implant to 18 months post device insertion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Objective Analysis Cohort
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 385
Measure Type: Number
Unit of Measure: percent of participants
29.3
2.Secondary Outcome
Title Predictors of the Incidence of AF
Hide Description 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 Frame Time from implant to date of last stored available device data (maximum of 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AF Predictors Analysis Cohort: AF Episodes AF Predictors Analysis Cohort: No AF Episodes
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 130 261
Measure Type: Count of Participants
Unit of Measure: Participants
Gender (Male)
67
  51.5%
138
  52.9%
Diabetes
80
  61.5%
168
  64.4%
Heart failure
31
  23.8%
50
  19.2%
Hypertension
122
  93.8%
244
  93.5%
Renal impairment
60
  46.2%
106
  40.6%
Chronic obstructive pulmonary disorder
19
  14.6%
57
  21.8%
Prior stroke > 1 year ago
23
  17.7%
56
  21.5%
Coronary artery disease
75
  57.7%
157
  60.2%
Sleep apnea
28
  21.5%
75
  28.7%
Family history of AF
5
   3.8%
3
   1.1%
Vascular disease
25
  19.2%
54
  20.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
1.05 to 1.11
Estimation Comments The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
1.01 to 1.08
Estimation Comments The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.77 to 1.61
Estimation Comments The hazard ratio represented the effect of being male on a patient's risk of developing AF.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.74 to 1.59
Estimation Comments The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.69 to 1.69
Estimation Comments The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.58 to 2.60
Estimation Comments The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.64 to 1.32
Estimation Comments The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.45 to 1.20
Estimation Comments The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.54 to 1.38
Estimation Comments The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.53 to 1.15
Estimation Comments The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.45 to 1.17
Estimation Comments The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
0.76 to 5.14
Estimation Comments The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection AF Predictors Analysis Cohort: AF Episodes, AF Predictors Analysis Cohort: No AF Episodes
Comments The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.56 to 1.43
Estimation Comments The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.
3.Secondary Outcome
Title Actions Taken in Response to Awareness of AF
Hide Description Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized
Time Frame Time from first identified episode of AF to study exit (maximum of 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title First Visit With AF Detected Second Visit With AF Detected Third Visit With AF Detected Fourth Visit With AF Detected Fifth Visit With AF Detected Sixth Visit With AF Detected
Hide Arm/Group Description:

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a follow-up visit in which new AF episodes were diagnosed

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a 2nd follow-up visit in which new AF episodes were diagnosed

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a 3rd follow-up visit in which new AF episodes were diagnosed

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a 4th follow-up visit in which new AF episodes were diagnosed

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a 5th follow-up visit in which new AF episodes were diagnosed

Enrolled subjects implanted with a Reveal Implantable Cardiac Monitor who:

  1. Did not have diagnosed AF prior to implant,
  2. 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),
  3. was not taking an anti-arrhythmic drug at enrollment, and
  4. Had a 6th follow-up visit in which new AF episodes were diagnosed
Overall Number of Participants Analyzed 115 57 31 20 12 6
Overall Number of Units Analyzed
Type of Units Analyzed: Actions at Visits
85 14 6 4 2 0
Count of Units
Unit of Measure: Actions at Visits
Oral Anticoagulation Initiated
61
  71.8%
5
  35.7%
0
   0.0%
1
  25.0%
2
 100.0%
0
Rhythm Control Medication Initiated
13
  15.3%
2
  14.3%
0
   0.0%
1
  25.0%
0
   0.0%
0
Rate Control Medication Initiated
4
   4.7%
3
  21.4%
2
  33.3%
1
  25.0%
0
   0.0%
0
Cardioversion
2
   2.4%
2
  14.3%
1
  16.7%
0
   0.0%
0
   0.0%
0
Ablation
0
   0.0%
2
  14.3%
3
  50.0%
1
  25.0%
0
   0.0%
0
Referral to Another Physician
5
   5.9%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
Time Frame Adverse events occurring from the time of enrollment (consent) until exit will be included. All subjects were to be followed a minimum of 18 months and a maximum of 30 months post-Reveal device implantation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reveal Implantable Cardiac Monitor Implant Attempted No Reveal Implantable Cardiac Monitor Implant Attempt
Hide Arm/Group Description Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted) Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor
All-Cause Mortality
Reveal Implantable Cardiac Monitor Implant Attempted No Reveal Implantable Cardiac Monitor Implant Attempt
Affected / at Risk (%) Affected / at Risk (%)
Total   13/395 (3.29%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Reveal Implantable Cardiac Monitor Implant Attempted No Reveal Implantable Cardiac Monitor Implant Attempt
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   153/395 (38.73%)      1/51 (1.96%)    
Cardiac disorders     
Atrial fibrillation  1  10/395 (2.53%)  10 0/51 (0.00%)  0
Sinus node dysfunction  1  9/395 (2.28%)  9 0/51 (0.00%)  0
Coronary artery disease  1  7/395 (1.77%)  7 0/51 (0.00%)  0
Acute myocardial infarction  1  5/395 (1.27%)  6 0/51 (0.00%)  0
Cardiac arrest  1  6/395 (1.52%)  6 0/51 (0.00%)  0
Cardiac failure  1  3/395 (0.76%)  6 0/51 (0.00%)  0
Cardiac failure congestive  1  3/395 (0.76%)  6 0/51 (0.00%)  0
Bradycardia  1  5/395 (1.27%)  5 0/51 (0.00%)  0
Atrioventricular block complete  1  4/395 (1.01%)  4 0/51 (0.00%)  0
Supraventricular tachycardia  1  3/395 (0.76%)  4 0/51 (0.00%)  0
Angina unstable  1  3/395 (0.76%)  3 0/51 (0.00%)  0
Ventricular tachycardia  1  3/395 (0.76%)  3 0/51 (0.00%)  0
Angina pectoris  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Atrial flutter  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Atrioventricular block second degree  1  1/395 (0.25%)  1 1/51 (1.96%)  1
Sinus bradycardia  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Ventricular extrasystoles  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Acute coronary syndrome  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Cardiac failure acute  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Coronary artery occlusion  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Left ventricular dysfunction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Myocardial infarction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Myocardial ischaemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Sinus arrest  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Ventricular fibrillation  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Inappropriate antidiuretic hormone secretion  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Gastrointestinal haemorrhage  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Inguinal hernia  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Small intestinal obstruction  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Constipation  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Gastritis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Intestinal obstruction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Oesophageal obstruction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Rectal polyp  1  1/395 (0.25%)  1 0/51 (0.00%)  0
General disorders     
Chest pain * 1  11/395 (2.78%)  15 0/51 (0.00%)  0
Implant site pain  1  4/395 (1.01%)  4 0/51 (0.00%)  0
Asthenia  1  3/395 (0.76%)  3 0/51 (0.00%)  0
Medical device site erosion  1  3/395 (0.76%)  3 0/51 (0.00%)  0
Death  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Adverse drug reaction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Device dislocation  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Discomfort  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hernia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Lead dislodgement  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Oversensing  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Sudden death  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hepatobiliary disorders     
Cholangitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Infections and infestations     
Pneumonia  1  6/395 (1.52%)  8 0/51 (0.00%)  0
Diverticulitis  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Implant site infection  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Appendicitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Bacteraemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Bronchitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Clostridium difficile colitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Cystitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Gangrene  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Gastroenteritis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Herpes zoster  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Kidney infection  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Pneumonia bacterial  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Sepsis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Septic shock  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Urinary tract infection  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Injury, poisoning and procedural complications     
Hip fracture  1  4/395 (1.01%)  4 0/51 (0.00%)  0
Fall  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Incisional hernia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Laceration  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Meniscus injury  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Muscle strain  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Post procedural haematoma  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Postoperative fever  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Investigations     
Blood pressure increased  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Metabolism and nutrition disorders     
Hyponatraemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hypovolaemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Muscle spasms  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Muscular weakness  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute promyelocytic leukaemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Adenocarcinoma  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Brain neoplasm  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Breast cancer  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Bronchial carcinoma  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Chronic lymphocytic leukaemia  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Colon cancer  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Nervous system disorders     
Transient ischaemic attack  1  8/395 (2.03%)  8 0/51 (0.00%)  0
Cerebrovascular accident  1  6/395 (1.52%)  6 0/51 (0.00%)  0
Syncope  1  5/395 (1.27%)  5 0/51 (0.00%)  0
Encephalopathy  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Basal ganglia stroke  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Central nervous system inflammation  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Cerebral infarction  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Dizziness  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Epilepsy  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Haemorrhage intracranial  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hepatic encephalopathy * 1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hypertensive encephalopathy  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Loss of consciousness  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Partial seizures  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Presyncope  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Seizure  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Sensory disturbance  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Psychiatric disorders     
Completed suicide  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Mental status changes  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Chronic kidney disease  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Acute prerenal failure  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Hydronephrosis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Renal failure  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Urinary incontinence * 1  1/395 (0.25%)  1 0/51 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  5/395 (1.27%)  5 0/51 (0.00%)  0
Chronic obstructive pulmonary disease  1  4/395 (1.01%)  4 0/51 (0.00%)  0
Pulmonary embolism  1  3/395 (0.76%)  3 0/51 (0.00%)  0
Vascular disorders     
Peripheral arterial occlusive disease  1  3/395 (0.76%)  5 0/51 (0.00%)  0
Peripheral vascular disorder  1  4/395 (1.01%)  5 0/51 (0.00%)  0
Hypertensive crisis  1  3/395 (0.76%)  4 0/51 (0.00%)  0
Hypertension  1  2/395 (0.51%)  2 0/51 (0.00%)  0
Orthostatic hypotension * 1  1/395 (0.25%)  2 0/51 (0.00%)  0
Aortic aneurysm  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Deep vein thrombosis  1  1/395 (0.25%)  1 0/51 (0.00%)  0
Shock  1  1/395 (0.25%)  1 0/51 (0.00%)  0
1
Term from vocabulary, MeDRA Preferred Term
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reveal Implantable Cardiac Monitor Implant Attempted No Reveal Implantable Cardiac Monitor Implant Attempt
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/395 (8.61%)      1/51 (1.96%)    
Cardiac disorders     
Atrial fibrillation * 1  34/395 (8.61%)  36 1/51 (1.96%)  1
1
Term from vocabulary, MeDRA Preferred Term
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and participating institutions will provide any publication of study data generated by the Investigator and/or participating institution to Medtronic for review prior to submission to determine if confidential information ("CI") is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.
Results Point of Contact
Name/Title: Medtronic Cardiac Rhythm and Heart Failure clinical trial manager
Organization: Medtronic, Inc.
Phone: 763-505-6000
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01727297     History of Changes
Other Study ID Numbers: REVEAL AF
First Submitted: November 12, 2012
First Posted: November 15, 2012
Results First Submitted: December 13, 2017
Results First Posted: March 29, 2018
Last Update Posted: April 30, 2018