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

NCT01090349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-02-04

No results posted yet for this study

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.

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

The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.

DEVICE

Merlin.NET PCN

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Janet McComb, MD · Freeman Hospital Newcastle; UK

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-04-30
Completion
2014-04-30

Countries

  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090349 on ClinicalTrials.gov