NL-OMON48493
Completed
Not Applicable
PREcision Event Monitoring of PatienTs with Heart Failure - PREEMPT-HF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- cardiac arrest
- Sponsor
- Boston Scientific
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is age 18 or above, or of legal age to give informed consent specific
- •country and national laws
- •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 Sensors turned ON, Respiratory 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
- •remotely monitored from the baseline visit for approximately 12 months with
Exclusion Criteria
- •Subject has received or is scheduled to receive a heart transplant or
- •ventricular assist device (VAD).
- •Subject is enrolled in any concurrent clinical study without prior
- •Boston Scientific written approval (excluding registries).
- •Subject has a life expectancy of less than 12 months.
- •Subject has a history of non\-compliance to medical care or known
- •inability to comply with requirements of the clinical study protocol.
Outcomes
Primary Outcomes
Not specified
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