Study of New Implantable Loop Recorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00746564
First received: September 2, 2008
Last updated: November 1, 2015
Last verified: November 2015
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Tachyarrhythmias
Syncope
Intervention: Device: SJM Confirm

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SJM Confirm Device All patients in this study received the St. Jude Medical (SJM Confirm device.

Participant Flow:   Overall Study
    SJM Confirm Device  
STARTED     75  
COMPLETED     73  
NOT COMPLETED     2  
Required Pacemaker/ICD Implant                 2  



  Baseline Characteristics
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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.
All patients implanted with the Confirm Device.

Reporting Groups
  Description
Open Label All patients who were implanted with the SJM Confirm device.

Baseline Measures
    Open Label  
Number of Participants  
[units: participants]
  75  
Age  
[units: years]
Mean (Full Range)
  62  
  (19 to 83)  
Gender  
[units: participants]
 
Female     31  
Male     44  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sensitivity for R Waves During In-Clinic Recordings at Rest   [ Time Frame: 6 weeks ]

2.  Primary:   Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise   [ Time Frame: 6 weeks ]

3.  Primary:   Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers   [ Time Frame: 6 weeks ]

4.  Primary:   Positive Predictive Value (PPV) for In-Clinic Recordings at Rest   [ Time Frame: 6 weeks ]

5.  Primary:   Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test   [ Time Frame: 6 weeks ]

6.  Primary:   Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers   [ Time Frame: 6 weeks ]

7.  Other Pre-specified:   Interpretability of Weekly Subject Activator Recordings   [ Time Frame: 6 weeks ]

8.  Other Pre-specified:   Interpretability of Automatically Triggered/Symptom Driven Recordings   [ Time Frame: 6 weeks ]

9.  Other Pre-specified:   Inappropriateness of Automatically Triggered Recordings – Phase I   [ Time Frame: 6 weeks ]

10.  Other Pre-specified:   Inappropriateness of Automatically Triggered Recordings – Phase II   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Director, Clinical Studies
Organization: St. Jude Medical
phone: 1-800-733-3455
e-mail: tshipman@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00746564     History of Changes
Other Study ID Numbers: 60020941D
Study First Received: September 2, 2008
Results First Received: April 13, 2015
Last Updated: November 1, 2015
Health Authority: United States: Food and Drug Administration