DEtermining Accuracy and TrEnding CharacTerization of AF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01673256
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : March 18, 2015
Last Update Posted : March 18, 2015
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
SJM Confirm ICM Observational Group SJM Confirm ICM

Participant Flow:   Overall Study
    SJM Confirm ICM Observational Group

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
SJM Confirm ICM Observational Group SJM Confirm ICM

Baseline Measures
   SJM Confirm ICM Observational Group 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 65.7  (9.6) 
[Units: Participants]
Female   35 
Male   55 
Region of Enrollment 
[Units: Participants]
Netherlands   5 
Germany   85 
[Units: Kg]
Mean (Standard Deviation)
 82.4  (16.4) 

  Outcome Measures

1.  Primary:   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.   [ Time Frame: 4 days after Holter starts ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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 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