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Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF)

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ClinicalTrials.gov Identifier: NCT00924638
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Cryptogenic Symptomatic Transient Ischemic Attack
Cryptogenic Ischemic Stroke
Intervention Device: Reveal® XT Insertable Cardiac Monitor
Enrollment 447
Recruitment Details A total of 447 subjects were enrolled in 55 study centers from 14 countries in North America and Europe, during the recruitment period of June 2009 to April 2012.
Pre-assignment Details A total of 6 enrolled subjects were exited from the study prior to randomization due to: Eligibility criteria not met (n=4), and Subject withdrew consent (n=2).
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Period Title: Overall Study
Started 221 [1] 220 [2]
Completed 209 [3] 207 [3]
Not Completed 12 13
Reason Not Completed
Death             3             2
Lost to Follow-up             1             1
Withdrawal by Subject             5             7
Physician Decision             3             3
[1]
Randomized to Continuous Monitoring Arm
[2]
Randomized to Control Arm
[3]
Completed 6 months of follow-up
Arm/Group Title Continuous Monitoring Control Arm Total
Hide Arm/Group Description

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor Total of all reporting groups
Overall Number of Baseline Participants 221 220 441
Hide Baseline Analysis Population Description
Intention-to-treat (ITT) population (all randomized subjects)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 221 participants 220 participants 441 participants
61.6  (11.4) 61.4  (11.3) 61.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 220 participants 441 participants
Female
79
  35.7%
82
  37.3%
161
  36.5%
Male
142
  64.3%
138
  62.7%
280
  63.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 221 participants 220 participants 441 participants
United States 80 66 146
Slovakia 1 3 4
Greece 1 0 1
Finland 0 2 2
Spain 0 5 5
Austria 23 16 39
Italy 28 31 59
France 17 17 34
Canada 3 6 9
Belgium 14 27 41
Denmark 3 3 6
Germany 39 32 71
Netherlands 12 11 23
Sweden 0 1 1
1.Primary Outcome
Title AF Detection Rate Within 6 Months
Hide Description Percentage of subjects with AF detected within 6 months of follow-up
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population (all randomized subjects)
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 221 220
Measure Type: Number
Unit of Measure: percentage of participants
8.9 1.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
1.9 to 21.7
Estimation Comments A hazard ratio of > 1 indicates that Continuous Monitoring is superior to Control in detecting AF.
2.Secondary Outcome
Title AF Detection Rate Within 12 Months
Hide Description Percentage of subjects with AF detected within 12 months of follow-up
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population (all randomized subjects)
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 221 220
Measure Type: Number
Unit of Measure: percentage of participants
12.4 2.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
2.6 to 20.8
Estimation Comments A hazard ratio of > 1 indicates that Continuous Monitoring is superior to Control in detecting AF.
3.Secondary Outcome
Title Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)
Hide Description Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population (all randomized subjects)
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 221 220
Measure Type: Number
Unit of Measure: percentage of participants
7.1 9.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.35 to 1.32
Estimation Comments A hazard ratio of < 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.
4.Secondary Outcome
Title Use of Oral Anticoagulation (OAC) Drugs
Hide Description Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the 12-months follow-up visit
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 197 185
Measure Type: Number
Unit of Measure: percentage of participants
14.7 6.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
2.8 to 14.8
Estimation Comments A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.
5.Secondary Outcome
Title Use of Antiarrhythmic Drugs
Hide Description Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who completed the 12 months follow-up visit
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 197 185
Measure Type: Number
Unit of Measure: percentage of participants
2.0 1.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-2.3 to 3.1
Estimation Comments A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.
6.Secondary Outcome
Title Health Outcome as Evaluated by EQ-5D Questionnaire
Hide Description 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).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who reported EQ-5D VAS score at the 12 months visit
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 191 183
Mean (Standard Deviation)
Unit of Measure: units on a scale of 0 to 100
78.9  (15.6) 76.3  (16.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Clinical Disease Burden and Care Pathway
Hide Description Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population (all randomized subjects)
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description:

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Overall Number of Participants Analyzed 221 220
Measure Type: Number
Unit of Measure: percentage of participants
10.5 7.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Continuous Monitoring, Control Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.73 to 2.60
Estimation Comments A hazard ratio of < 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.
8.Secondary Outcome
Title Impact of Patient Assistant Use on AF Diagnosis
Hide Description AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency
Time Frame Follow-up closure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study
Arm/Group Title Continuous Monitoring
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: days from AF occurrence to AF diagnosis
PA used everyday 14.0  (35.6)
PA used most of the time (5-6 days/week) 25.0  (31.4)
PA used sometimes (3-4 days/week) 174.8  (235.9)
PA used rarely (1-2 days/week) 15.3  (9.3)
PA never used 92.0 [1]   (NA)
PA use frequency not reported 20.0 [1]   (NA)
[1]
Only one observation was available
Time Frame Adverse events were collected throughout the study (from enrollment to exit). Average subject follow-up duration was 19.7 +/- 9.7 months (range: 0 - 42.7 months).
Adverse Event Reporting Description Subjects were assessed for adverse events through scheduled follow-up visits at 6 month intervals, as well as through unscheduled visits as adverse events occur.
 
Arm/Group Title Continuous Monitoring Control Arm
Hide Arm/Group Description

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.

Follow-up at the same frequency, but with no Insertable Cardiac Monitor
All-Cause Mortality
Continuous Monitoring Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Continuous Monitoring Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/221 (30.77%)      58/220 (26.36%)    
Blood and lymphatic system disorders     
Anaemia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Iron deficiency anaemia  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Cardiac disorders     
Angina pectoris  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Angina unstable  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Aortic valve stenosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Atrial fibrillation  1  6/221 (2.71%)  6 3/220 (1.36%)  3
Atrial flutter  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Atrioventricular block second degree  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Bradycardia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Cardiac arrest  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Cardiac failure  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Coronary artery disease  1  2/221 (0.90%)  3 2/220 (0.91%)  2
Coronary artery stenosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Sick sinus syndrome  1  3/221 (1.36%)  3 0/220 (0.00%)  0
Supraventricular tachycardia  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Tachyarrhythmia  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Tachycardia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Ventricular tachycardia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Wolff-Parkinson-White syndrome  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Congenital, familial and genetic disorders     
Atrial septal defect  1  3/221 (1.36%)  3 5/220 (2.27%)  5
Ear and labyrinth disorders     
Vertigo  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Eye disorders     
Macular degeneration  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Retinal artery embolism  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Retinal artery occlusion  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Colonic polyp  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Diverticulum  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Gastrointestinal haemorrhage  1  2/221 (0.90%)  2 1/220 (0.45%)  1
Rectal haemorrhage  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Small intestinal obstruction  1  1/221 (0.45%)  1 1/220 (0.45%)  1
General disorders     
Adverse drug reaction  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Asthenia  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Chest pain  1  5/221 (2.26%)  5 0/220 (0.00%)  0
Gait disturbance  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Non-cardiac chest pain  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Pyrexia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Sudden death  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Clostridium difficile colitis  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Enteritis infectious  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Gastroenteritis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Implant site infection  1  3/221 (1.36%)  3 1/220 (0.45%)  1
Localised infection  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Pneumonia  1  2/221 (0.90%)  3 2/220 (0.91%)  2
Sepsis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Urinary tract infection  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Urosepsis  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Injury, poisoning and procedural complications     
Face injury  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Fall  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Femur fracture  1  2/221 (0.90%)  2 1/220 (0.45%)  1
Head injury  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hip fracture  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Humerus fracture  1  1/221 (0.45%)  1 1/220 (0.45%)  1
In-stent arterial restenosis  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Joint injury  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Lower limb fracture  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Lumbar vertebral fracture  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Meniscus lesion  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Pocket erosion  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Road traffic accident  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Metabolism and nutrition disorders     
Dehydration  1  3/221 (1.36%)  3 0/220 (0.00%)  0
Hypoalbuminaemia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hypokalaemia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hypomagnesaemia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hyponatraemia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Chondrolysis  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Chondropathy  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Costochondritis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Intervertebral disc protrusion  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Meniscal degeneration  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Musculoskeletal pain  1  1/221 (0.45%)  1 1/220 (0.45%)  1
Osteoarthritis  1  1/221 (0.45%)  2 0/220 (0.00%)  0
Rotator cuff syndrome  1  1/221 (0.45%)  1 1/220 (0.45%)  1
Soft tissue disorder  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Bronchial carcinoma  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Colon cancer  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Glioblastoma multiforme  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Lung adenocarcinoma metastatic  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Malignant melanoma  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Neoplasm malignant  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Neuroendocrine carcinoma  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Nervous system disorders     
Aphasia  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Carotid artery stenosis  1  0/221 (0.00%)  0 2/220 (0.91%)  2
Cerebral haemorrhage  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Cerebral infarction  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Cerebrovascular accident  1  11/221 (4.98%)  12 5/220 (2.27%)  5
Cerebrovascular spasm  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Dizziness  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Dysarthria  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Epilepsy  1  1/221 (0.45%)  1 2/220 (0.91%)  2
Migraine  1  1/221 (0.45%)  1 1/220 (0.45%)  1
Syncope  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Tension headache  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Transient ischaemic attack  1  6/221 (2.71%)  6 9/220 (4.09%)  9
Psychiatric disorders     
Depression  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Mental status changes  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Somatisation disorder  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Renal and urinary disorders     
Calculus ureteric  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Dysuria  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Nephrolithiasis  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Nephropathy  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Renal artery stenosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Renal failure  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Ureteric obstruction  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Urethral disorder  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Reproductive system and breast disorders     
Adnexa uteri mass  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Cystocele  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/221 (0.45%)  2 0/220 (0.00%)  0
Pleural effusion  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Pulmonary embolism  1  0/221 (0.00%)  0 2/220 (0.91%)  2
Pulmonary oedema  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Surgical and medical procedures     
Medical device removal  1  2/221 (0.90%)  2 0/220 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Femoral arterial stenosis  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Hypertension  1  0/221 (0.00%)  0 1/220 (0.45%)  1
Hypertensive crisis  1  3/221 (1.36%)  3 0/220 (0.00%)  0
Hypotension  1  0/221 (0.00%)  0 2/220 (0.91%)  2
Peripheral arterial occlusive disease  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Peripheral vascular disorder  1  1/221 (0.45%)  1 0/220 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Continuous Monitoring Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/221 (18.55%)      9/220 (4.09%)    
Cardiac disorders     
Atrial fibrillation  1  41/221 (18.55%)  60 9/220 (4.09%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medtronic CRDM clinical trial manager
Organization: Medtronic, Inc.
Phone: 763-505-6000
EMail: medtronicCRMtrials@medtronic.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00924638    
Other Study ID Numbers: CRYSTAL-AF
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: June 26, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014