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Clinical Trials/NL-OMON48493
NL-OMON48493
Completed
Not Applicable

PREcision Event Monitoring of PatienTs with Heart Failure - PREEMPT-HF

Boston Scientific0 sites120 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

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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