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

• 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

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)

Dr. Ralph Bosch; 🇩🇪 Ludwigsburg, Germany

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom