Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, A-Fib, AF, Persistent, Permanent, Pulmonary Vein isolation, Ablation
Brief summary
The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.
Interventions
DEVICEReveal XT implantable loop recorder
All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
Sponsors
Medtronic
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years * Undergoing ablation for atrial fibrillation at the University of Pennsylvania
Exclusion criteria
* Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Burden | 6 and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Actionable Events Resulting in Change of Clinical Care | 12 months | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 20 |
| Total | 38 |
Baseline characteristics
| Characteristic | Reveal XT | Total | Conventional Monitoring Strategy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 16 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 22 Participants | 11 Participants |
| Age, Continuous | 61 Years STANDARD_DEVIATION 9 | 59.4 Years STANDARD_DEVIATION 11 | 57 Years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 0 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
Arrhythmia Burden
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Monitoring Strategy | Arrhythmia Burden | First 6 months (non randomized) | 7 Participants |
| Conventional Monitoring Strategy | Arrhythmia Burden | 6 -12 months (randomized) | 5 Participants |
| Reveal XT | Arrhythmia Burden | First 6 months (non randomized) | 18 Participants |
| Reveal XT | Arrhythmia Burden | 6 -12 months (randomized) | 5 Participants |
| Reveal XT and Conventional Monitoring | Arrhythmia Burden | First 6 months (non randomized) | 18 Participants |
Secondary
Detection of Actionable Events Resulting in Change of Clinical Care
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
Population: Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Conventional Monitoring Strategy | Detection of Actionable Events Resulting in Change of Clinical Care | 0 Participants |
| Reveal XT | Detection of Actionable Events Resulting in Change of Clinical Care | 5 Participants |