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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Monitoring Strategy | No Intervention | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal XT implantable loop recorder | Device | All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Dixit, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23577826 | Result | Kapa S, Epstein AE, Callans DJ, Garcia FC, Lin D, Bala R, Riley MP, Hutchinson MD, Gerstenfeld EP, Tzou W, Marchlinski FE, Frankel DS, Cooper JM, Supple G, Deo R, Verdino RJ, Patel VV, Dixit S. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | CM and Reveal XT | This was the non-randomized phase of the study in the first six months of evaluation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 - 6 Months (Ron-randomized) |
| |||||||||||||
| 6 - 12 Months (Randomized) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Reveal XT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 6 and 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Dixit | Hospital of the University of Pennsylvania | 215-615-4337 | sanjay.dixit@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 12 months |
| NOT COMPLETED |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | Reveal XT and Conventional Monitoring | This was the non-randomized phase of the study in the first six months of evaluation. |
|
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| 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. | Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |