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REVEAL AF: Incidence of AF in High Risk Patients

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ClinicalTrials.gov Identifier: NCT01727297
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : March 29, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition: Atrial Fibrillation
Intervention: Device: REVEAL Implantable 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
Patients in the 'No Reveal Implantable Cardiac Monitor Implant Attempt' arm were exited from the study prior to an implant attempt. Therefore, no outcome data are available. Baseline data are not presented due to variable data collection before the time of exit. Adverse event data were collected for this cohort, and are reported below.

Reporting Groups
  Description
Reveal Implantable Cardiac Monitor Implant Attempted Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)
No Reveal Implantable Cardiac Monitor Implant Attempt Enrolled subjects who exited the study prior to undergoing a procedure to implant a Reveal Implantable Cardiac Monitor

Participant Flow:   Overall Study
    Reveal Implantable Cardiac Monitor Implant Attempted   No Reveal Implantable Cardiac Monitor Implant Attempt
STARTED   395   51 
COMPLETED   293   0 
NOT COMPLETED   102   51 
Death                13                0 
Protocol Violation                1                10 
Adverse Event                3                1 
Lost to Follow-up                11                0 
Withdrawal by Subject                26                27 
Physician Decision                19                5 
Other (e.g. AF detection pre-implant)                29                8 



  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
Reveal Implantable Cardiac Monitor Implant Attempted Enrolled subjects who had a Reveal Implantable Cardiac Monitor implant attempt (i.e. underwent the procedure to have a Reveal device implanted)

Baseline Measures
   Reveal Implantable Cardiac Monitor Implant Attempted 
Overall Participants Analyzed 
[Units: Participants]
 395 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      88  22.3% 
>=65 years      307  77.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.6  (9.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      188  47.6% 
Male      207  52.4% 
Region of Enrollment 
[Units: Participants]
 
Austria   18 
Netherlands   6 
United States   302 
Italy   19 
Slovenia   4 
Germany   39 
Spain   7 


  Outcome Measures

1.  Primary:   18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes   [ Time Frame: Implant to 18 months post device insertion ]

2.  Secondary:   Predictors of the Incidence of AF   [ Time Frame: Time from implant to date of last stored available device data (maximum of 30 months) ]

3.  Secondary:   Actions Taken in Response to Awareness of AF   [ Time Frame: Time from first identified episode of AF to study exit (maximum of 30 months) ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medtronic Cardiac Rhythm and Heart Failure clinical trial manager
Organization: Medtronic, Inc.
phone: 763-505-6000
e-mail: medtronicCRMtrials@medtronic.com


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

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01727297     History of Changes
Other Study ID Numbers: REVEAL AF
First Submitted: November 12, 2012
First Posted: November 15, 2012
Results First Submitted: December 13, 2017
Results First Posted: March 29, 2018
Last Update Posted: April 30, 2018