CRC_C1926

PREEMPT-HF Precision Event Monitoring of Patients with Heart Failure using HeartLogic

The goal of PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of HeartLogic. Heart Failure Diagnostic (HeartLogic) is a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for the study.

Key Inclusion Criteria:

Subject has a documented diagnosis of heart failure.

Subject has a Boston Scientific CRT-D or ICD device implant that has HeartLogic, with Heart Failure Sensor turned ON, Respirator Sensor turned ON, and Sleep Incline Sensor turned ON.

Subject has an active bipolar RV lead implant.

Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled.
N/A
Heart and Vascular
Heart Failure
Vivek Bhatia, M.D.
Boston Scientific
Rebecca Watson
  • Providence Regional Medical Center Everett