Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk "IMPACT"

Terminated

Phase 4 Results

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