Clinical evaluation of Remote monitoring with dirEct Alerts* to reduCe Time from event to clinical decisio

Completed

Conditions: Detection of a heart event via Merlin.net PCN / detection of a heart event via home monitoring
10007521

Registration Number: NL-OMON36356

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for the investigation is the time between the detection of<br /><br>an event and the point in time when the physician or delegate takes a clinical<br /><br>decision.<br /><br><br /><br>Detection of an event =<br /><br>The time when the implanted device (ICD or CRT-D) triggers an alert. The alert<br /><br>is based on a change in value outside the default or programmed limits.<br /><br><br /><br>Clinical decision =<br /><br>When the physician or delegate determines if an action is required to follow-up<br /><br>on the event; or an action is not required to follow-up on the event</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* % of all events for which a clinical decision could be taken based on the<br /><br>device data retrieved during the Remote Monitoring review.<br /><br>* Physician or delegate time spent during in-clinic and remote follow up (both<br /><br>protocol required scheduled and unscheduled follow ups) and daily remote<br /><br>monitoring review. </p><br>