Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision

Study Overview
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Brief Summary
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St. Jude Medical developed the Merlin.net™ Patient Care Network (Merlin.net™ PCN) to augment or replace routine scheduled in-clinic visits. This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.

Official Title
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CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)

Conditions
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The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device

Intervention / Treatment
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* Device: Implantation of an ICD/CRT-D device
* Device: Merlin.NET PCN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient meets ACC/AHA/ESC guidelines for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT-D) device The 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) The patient has a life expectancy of greater than 12 months (based on the physician's discretion). The patient is mentally capable to participate in the investigation (based on the physician's discretion). The patient is 18 years of age or older Exclusion Criteria: The patient is being actively considered for cardiac transplantation. The patient has primary valvular disease that has not been corrected. The patient had a myocardial infarction within the last month The patient had unstable angina within the last month. The patient has had Coronary Artery Bypass Grafting (CABG) within the last month. The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month. The patient is pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct Alerts ON<br>Direct Alerts in implantable device were turned on | Device: Implantation of an ICD/CRT-D device<br>* The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.<br>* Other names: The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.;Device: Merlin.NET PCN<br>* The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems<br>* Other names: Merlin.NET;|
| Active Comparator: Direct Alerts OFF<br>Direct Alerts in implantable device were turned off | Device: Implantation of an ICD/CRT-D device<br>* The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.<br>* Other names: The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.;Device: Merlin.NET PCN<br>* The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems<br>* Other names: Merlin.NET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time between the detection of an event and the point in time when the physician or delegate takes a clinical decision |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision |  | 2 years | 
| The physician or delegate time required for remote follow up as compared to in-clinic follow up |  | 2 years | 
| The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRTD, Remote Care