Reveal In-Office Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01168427
First received: July 21, 2010
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: June 19, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Arrhythmias, Cardiac
Intervention: Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor

  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
Enrollment Cohort Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.

Participant Flow:   Overall Study
    Enrollment Cohort  
STARTED     66  
COMPLETED     65  
NOT COMPLETED     1  
Patient exited prior to implant                 1  



  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.
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Reporting Groups
  Description
Enrollment Cohort Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.

Baseline Measures
    Enrollment Cohort  
Number of Participants  
[units: participants]
  66  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     25  
Age  
[units: years]
Mean ± Standard Deviation
  59.9  ± 17.98  
Gender  
[units: participants]
 
Female     30  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     66  



  Outcome Measures
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1.  Primary:   Procedure-related Complications Rate Requiring Resolution by Surgical Intervention   [ Time Frame: From Implant to 90 days post-implant procedure ]

2.  Secondary:   Number of Participants Having Procedure-related Adverse Events   [ Time Frame: From Implant to 90 days post-implant procedure ]

3.  Secondary:   Surgical Staff Utilized for Reveal In-office Implants   [ Time Frame: At implant ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No

4.  Secondary:   Techniques and Procedures Utilized During Reveal In-office Implants   [ Time Frame: At implant ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No

5.  Secondary:   Physician Satisfaction With Reveal In-office Implants   [ Time Frame: At implant ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No

6.  Secondary:   R-wave Amplitude Measurement   [ Time Frame: Implant procedure and 30 days post-implant procedure ]
Results not yet posted.   Anticipated Posting Date:   09/2012   Safety Issue:   No


  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 NOT 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: RIO Clinical Research Specialist.
Organization: Medtronic - CRDM
phone: 1-800-328-2518 ext 63277
e-mail: MedtronicCRMtrials@medtronic.com


Publications:

Publications automatically indexed to this study:

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01168427     History of Changes
Other Study ID Numbers: Reveal In-Office Implants
Study First Received: July 21, 2010
Results First Received: June 19, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board