Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).
Interventions
OTHERDrug (Direct thrombin or Factor Xa inhibitor)
Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a St Jude Medial device that is compatible with Merlin.net (remote monitoring) * Patient has history of atrial fibrillation (non-continuous) * Patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation * Patient is willing to complete a questionnaire
Exclusion criteria
* Patient is in atrial fibrillation all of the time * Patient has a history of stroke or blood clot * Patient is on warfarin or coumadin * Patient cannot be taken off of his blood thinner medication due to another medical condition * Patient is not capable of sending a remote device transmission to doctor once a week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cumulative Days on Anticoagulation | one year | To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor. | 16 |
| Tailored Anticoagulation Tailored Anticoagulation (TAC): Anticoagulation to be stopped/started per device information. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed.
Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden). | 48 |
| Total | 64 |
Baseline characteristics
| Characteristic | Tailored Anticoagulation | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 13 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 3 Participants | 15 Participants |
| Age, Continuous | 71.3 years STANDARD_DEVIATION 10.2 | 75.0 years STANDARD_DEVIATION 11.1 | 72.2 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 48 participants | 16 participants | 64 participants |
| Sex: Female, Male Female | 17 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Male | 31 Participants | 10 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 2 / 48 |
| other Total, other adverse events | 5 / 16 | 9 / 48 |
| serious Total, serious adverse events | 3 / 16 | 8 / 48 |
Outcome results
Primary
Total Cumulative Days on Anticoagulation
To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden.
Time frame: one year
Population: After a 30-day run-in period during which anticoagulation use could not be stopped per study protocol, a total of 14,826 cumulative days of monitoring were completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Total Cumulative Days on Anticoagulation | 5840 days on anticoagulation |
| Tailored Anticoagulation | Total Cumulative Days on Anticoagulation | 3763 days on anticoagulation |