Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision

CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)

St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits.

This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.

Inclusion Criteria:

• The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device
• The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
• The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
• The patient is mentally capable to participate in the investigation (based on the physician's discretion).
• The patient is 18 years of age or older

Exclusion Criteria:

• The patient is being actively considered for cardiac transplantation.
• The patient has primary valvular disease that has not been corrected.
• The patient had a myocardial infarction within the last month
• The patient had unstable angina within the last month.
• The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
• The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
• The patient is pregnant.