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Clinical Trials/NL-OMON36356
NL-OMON36356
Completed
Not Applicable

Clinical evaluation of Remote monitoring with dirEct Alerts* to reduCe Time from event to clinical decision - REACT

St. Jude Medical0 sites10 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Detection of a heart event via Merlin.net PCN / detection of a heart event via home monitoring
Sponsor
St. Jude Medical
Enrollment
10
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) of cardiac resynchronization therapy (CRT\-D) device
  • \- 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)
  • \- Patient has a life expectancy of greater than 12 months (based on the physician's discretion)
  • \- Patient is mentally capable to participate in the investigation (based on the physician's dicretion)
  • \- Patient is 18 years of age or older

Exclusion Criteria

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

Outcomes

Primary Outcomes

Not specified

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