Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk (IMPACT)
Atrial Fibrillation, Atrial Flutter, Stroke
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Implanted Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Home Monitoring, Oral Anticoagulation
Eligibility Criteria
Key Inclusion Criteria:
- Candidates for implantation of, or already implanted with, a BIOTRONIK Lumax HF-T or DR-T device
- Documented P wave mean amplitude ≥ 1.0 mV (sinus rhythm) or ≥ 0.5 mV (AF) at enrollment, if previously implanted
- CHADS2 risk score ≥ 1
- Able and willing to follow OAC therapy if the indication develops during the course of the trial
- Able to utilize the HM throughout the study
Key Exclusion Criteria:
- Permanent AF
- History of stroke, transient ischemic attack (TIA) or systemic embolism and documented AF or AFL
- Currently requiring OAC therapy for any indication
- Patients who underwent successful AF ablation (sinus rhythm restored) and have not completed a minimum of 3 months of OAC therapy
- Known, current contraindication to use of eligible OAC
- Long QT or Brugada syndrome as the sole indication for device implantation
- Life expectancy less than the expected term of the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Home Monitoring Guided OAC
Physician-Directed OAC
Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of OAC.
In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed OAC consistent with current standards of care. Safety Net data include: ERI/EOS Special Implant Status Implant in Backup Mode (ROM) VT/ VF Detection Inactive Emergency Pacing 250 Ω > RV Pacing Impedance > 1500 Ω Symptomatic VT/VF therapies including both ATP and shock VT/VF storm HM transmission failure >3 days