NL-OMON36356
Completed
Not Applicable
Clinical evaluation of Remote monitoring with dirEct Alerts* to reduCe Time from event to clinical decision - REACT
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.
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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