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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
Enrollment 44
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Conventional Monitoring Strategy Reveal XT CM and Reveal XT
Hide Arm/Group Description 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.

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.

This was the non-randomized phase of the study in the first six months of evaluation.
Period Title: 1 - 6 Months (Ron-randomized)
Started 0 0 38
Completed 0 0 38
Not Completed 0 0 0
Period Title: 6 - 12 Months (Randomized)
Started 18 20 0
Completed 13 20 0
Not Completed 5 0 0
Arm/Group Title Conventional Monitoring Strategy Reveal XT Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 18 20 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 38 participants
<=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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 20 participants 38 participants
57  (12) 61  (9) 59.4  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 38 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 20 participants 38 participants
18 20 0
1.Primary Outcome
Title Arrhythmia Burden
Hide Description The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.
Time Frame 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Some participants withdrew before completing the full 1 year of required follow-up. In the first 6 months all 38 of the remaining patients arrhythmia recurrence was assessed using CM and Reveal XT. Participants were randomized in this phase to either CM or Reveal XT arms.
Arm/Group Title Conventional Monitoring Strategy Reveal XT Reveal XT and Conventional Monitoring
Hide Arm/Group Description:
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.

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.

This was the non-randomized phase of the study in the first six months of evaluation.
Overall Number of Participants Analyzed 38 38 38
Measure Type: Count of Participants
Unit of Measure: Participants
First 6 months (non randomized) Number Analyzed 38 participants 38 participants 38 participants
7
  18.4%
18
  47.4%
18
  47.4%
6 -12 months (randomized) Number Analyzed 13 participants 20 participants 0 participants
5
  38.5%
5
  25.0%
2.Secondary Outcome
Title Detection of Actionable Events Resulting in Change of Clinical Care
Hide Description Change of clinical care include initiation of previously discontinued and/or new anti-arrhythmic drugs, decision for repeat ablation, hospitalization for arrhythmias, discontinuation or reinitiation of atrio-ventricular nodal blocking agents, discontinuation or reinitiation af anticoagulation after ablation and/or decision to implant a pacemaker and/or defibrillator.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety.
Arm/Group Title Conventional Monitoring Strategy Reveal XT
Hide Arm/Group Description:
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.

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.

For details, please refer to the following citation of the published study: Kapa, et al, Journal of Cardiovascular Electrophysiology 2013; DOI:10.1111/JCE. 12141

Overall Number of Participants Analyzed 38 38
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5
  13.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Conventional Monitoring Strategy Reveal XT
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Conventional Monitoring Strategy Reveal XT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional Monitoring Strategy Reveal XT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional Monitoring Strategy Reveal XT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/20 (0.00%) 
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
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