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OpenTrials
Completed

NCT Number: NCT01090349

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Ralph Bosch, Ludwigsburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantation of an ICD/CRT-D device

Device

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

Other names: The SJM ICD family of devices with the Invisilink feature are the AnalyST™ and /AnalyST Accel™ and Current™/CurrentTM RF/Current AccelTM., The SJM CRT-D family of devices with the Invisilink feature is the Promote™/PromoteTM RF.

Merlin.NET PCN

Device

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

Other names: Merlin.NET

Primary outcomes

  1. time between the detection of an event and the point in time when the physician or delegate takes a clinical decision

    Time frame: 2 years

Secondary outcomes

  1. The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision

    Time frame: 2 years

  2. The physician or delegate time required for remote follow up as compared to in-clinic follow up

    Time frame: 2 years

  3. The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: REACT

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Mar 19, 2010
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.