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Reveal In-Office Implants

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ClinicalTrials.gov Identifier: NCT01168427
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : July 26, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Arrhythmias, Cardiac
Intervention: Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor

  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
  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

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
  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 
Overall Participants Analyzed 
[Units: Participants]
 66 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      41  62.1% 
>=65 years      25  37.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.9  (17.98) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      30  45.5% 
Male      36  54.5% 
Region of Enrollment 
[Units: Participants]
 
United States   66 


  Outcome Measures

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 reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Techniques and Procedures Utilized During Reveal In-office Implants   [ Time Frame: At implant ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Physician Satisfaction With Reveal In-office Implants   [ Time Frame: At implant ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   R-wave Amplitude Measurement   [ Time Frame: Implant procedure and 30 days post-implant procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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:
Vater M., Rameken M., Pitschner H.F., et al. The endless-loop-recorder in clinical practice - Results of the multicentre German Reveal® registry. Herzschrittmachertherapie und Elektrophysiologie (2002) 13:2 (101-109).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01168427     History of Changes
Other Study ID Numbers: Reveal In-Office Implants
First Submitted: July 21, 2010
First Posted: July 23, 2010
Results First Submitted: June 19, 2012
Results First Posted: July 26, 2012
Last Update Posted: February 28, 2018