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Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)

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ClinicalTrials.gov Identifier: NCT01176617
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Atrial Fibrillation
Intervention: Device: Reveal XT implantable loop recorder

  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
44 patients were enrolled over 4 months; 6 patients withdrew: 4 patients had the device removed before study completion and 2 patients did not return for the required follow-up. The remaining 38 patients completed the study requirements and are reported in the final results.

Reporting Groups
  Description
Conventional Monitoring Strategy Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
Reveal XT

Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.

Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.

CM and Reveal XT This was the non-randomized phase of the study in the first six months of evaluation.

Participant Flow for 2 periods

Period 1:   1 - 6 Months (Ron-randomized)
    Conventional Monitoring Strategy   Reveal XT   CM and Reveal XT
STARTED   0   0   38 
COMPLETED   0   0   38 
NOT COMPLETED   0   0   0 

Period 2:   6 - 12 Months (Randomized)
    Conventional Monitoring Strategy   Reveal XT   CM and Reveal XT
STARTED   18   20   0 
COMPLETED   13   20   0 
NOT COMPLETED   5   0   0 



  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
Conventional Monitoring Strategy Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.
Reveal XT

Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.

Reveal XT implantable loop recorder: All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.

Total Total of all reporting groups

Baseline Measures
   Conventional Monitoring Strategy   Reveal XT   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   20   38 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed   18   20   38 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      11  61.1%      11  55.0%      22  57.9% 
>=65 years      7  38.9%      9  45.0%      16  42.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   18   20   38 
   57  (12)   61  (9)   59.4  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   18   20   38 
Female      2  11.1%      3  15.0%      5  13.2% 
Male      16  88.9%      17  85.0%      33  86.8% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   0   0   0 
         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   18   20   38 
United States   18   20   0 


  Outcome Measures

1.  Primary:   Arrhythmia Burden   [ Time Frame: 6 and 12 months ]

2.  Secondary:   Detection of Actionable Events Resulting in Change of Clinical Care   [ Time Frame: 12 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 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: Dr. Sanjay Dixit
Organization: Hospital of the University of Pennsylvania
phone: 215-615-4337
e-mail: sanjay.dixit@uphs.upenn.edu


Publications of Results:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01176617     History of Changes
Other Study ID Numbers: UPenn811675
First Submitted: August 4, 2010
First Posted: August 6, 2010
Results First Submitted: April 19, 2017
Results First Posted: April 5, 2018
Last Update Posted: April 5, 2018