Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Merlin PCN
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01090349
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE March 18, 2010
First Posted Date  ICMJE March 19, 2010
Last Update Posted Date February 4, 2019
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2010)
  • The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision [ Time Frame: 2 years ]
  • The physician or delegate time required for remote follow up as compared to in-clinic follow up [ Time Frame: 2 years ]
  • The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
Official Title  ICMJE CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE The Patient Meets ACC/AHA/ESC Guidelines for Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) Device
Intervention  ICMJE
  • 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.
    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.
  • 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
    Other Name: Merlin.NET
Study Arms  ICMJE
  • Experimental: Direct Alerts ON
    Direct Alerts in implantable device were turned on
    Interventions:
    • Device: Implantation of an ICD/CRT-D device
    • Device: Merlin.NET PCN
  • Active Comparator: Direct Alerts OFF
    Direct Alerts in implantable device were turned off
    Interventions:
    • Device: Implantation of an ICD/CRT-D device
    • Device: Merlin.NET PCN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2010)
200
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01090349
Other Study ID Numbers  ICMJE CR-09-064-WW-RC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet McComb, MD Freeman Hospital Newcastle; UK
PRS Account Abbott Medical Devices
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP