HVP Precision Event Monitoring for Patients With Heart Failure Using HeartLogic™ (PREEMPT-HF)
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). There are no primary safety and/or efficacy endpoints for this study.
Subjects will be followed for approximately 12 months.
Key Inclusion Criteria:
1. Subject is age 18 or above.
2. Subject has a documented diagnosis of heart failure.
3. Subject has a Boston Scientific CRT-D or ICD device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON.
4. Subject has an active bipolar RV lead implant.
5. 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.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Heart and Vascular
Scott Brancato, M.D.
- Providence Portland Medical Center
- Providence St. Vincent Medical Center
- TOC Gateway - Heart Clinic