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

Atrial fibrillation (AF) and atrial flutter (AFL) are common cardiac arrhythmias associated
with an increased incidence of stroke in patients with additional risk factors. Oral
Anticoagulation (OAC) reduces stroke risk, but because these arrhythmias are frequently
intermittent and asymptomatic, start of OAC therapy is often delayed until
electrocardiographic documentation is obtained.

Technological advances in implanted dual-chamber cardioverter defibrillator (ICD) or cardiac
resynchronization therapy defibrillator (CRT-D) devices allow early detection and real time
verification of AF/AFL with intracardiac electrograms (IEGM) automatically transmitted to the
clinicians. Such remote diagnostic capability might be particularly relevant in patients with
asymptomatic AF by allowing timely treatment. Compared to conventional periodic, (e.g.,
quarterly) office device evaluation, daily remote monitoring may prove superior for diagnosis
of AF and prophylactic treatment of thromboembolism.

The start, stop and restart of OAC based on a predefined atrial rhythm-guided strategy in
conjunction with a standard risk-stratification scheme could lead to better clinical outcomes
compared with conventional clinical care. The study is designed to demonstrate a risk
reduction of both thromboembolism proximate to episodes of documented AF/AFL and bleeding
potentiated by chronic OAC in the absence of AF. Verification of this premise would impact
the clinical practice, providing evidence to physicians for the use of HM to guide OAC in
patients with AF/AFL. The results of this study should demonstrate the clinical value of
wireless remote surveillance of the cardiac rhythm and may define the critical threshold of
AF/AFL burden warranting OAC or antiarrhythmic drug therapy in patients at risk of stroke

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