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DEtermining Accuracy and TrEnding CharacTerization of AF

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ClinicalTrials.gov Identifier: NCT01673256
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Atrial Fibrillation
Intervention Device: SJM Confirm ICM
Enrollment 90

Recruitment Details  
Pre-assignment Details  
Arm/Group Title SJM Confirm ICM Observational Group
Hide Arm/Group Description SJM Confirm ICM
Period Title: Overall Study
Started 90
Completed 90
Not Completed 0
Arm/Group Title SJM Confirm ICM Observational Group
Hide Arm/Group Description SJM Confirm ICM
Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants
65.7  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
35
  38.9%
Male
55
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants
Netherlands 5
Germany 85
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 90 participants
82.4  (16.4)
1.Primary Outcome
Title Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
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Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.

Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.

Time Frame 4 days after Holter starts
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title SJM Confirm ICM Observational Group
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SJM Confirm ICM
Overall Number of Participants Analyzed 79
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
Duration Sensitivity
83.9
(71.6 to 96.1)
Duration Positive Predictive Value
97.3
(91.9 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SJM Confirm ICM Observational Group
Hide Arm/Group Description SJM Confirm ICM
All-Cause Mortality
SJM Confirm ICM Observational Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SJM Confirm ICM Observational Group
Affected / at Risk (%)
Total   0/90 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SJM Confirm ICM Observational Group
Affected / at Risk (%)
Total   0/90 (0.00%) 
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
Name/Title: Kyle Brunner
Organization: St. Jude Medical Inc.
Phone: 651.756.3482
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01673256     History of Changes
Other Study ID Numbers: DETECT AF
First Submitted: August 22, 2012
First Posted: August 27, 2012
Results First Submitted: January 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: March 18, 2015