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

Not Applicable

Completed

• Conditions: The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
• Interventions: Device: Implantation of an ICD/CRT-D device; Device: Merlin.NET PCN

• Registration Number: NCT01090349
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-18
• Study First Posted: 2010-03-19
• Primary Completion: 2012-04
• Study Completion: 2014-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Alerts ON	Merlin.NET PCN	Direct Alerts in implantable device were turned on
Direct Alerts OFF	Implantation of an ICD/CRT-D device	Direct Alerts in implantable device were turned off
Direct Alerts OFF	Merlin.NET PCN	Direct Alerts in implantable device were turned off
Direct Alerts ON	Implantation of an ICD/CRT-D device	Direct Alerts in implantable device were turned on

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Dr. Ralph Bosch; 🇩🇪 Ludwigsburg, Germany