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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01090349
First received: March 18, 2010
Last updated: September 24, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: CLINICAL EVALUATION OF REMOTE MONITORING WITH DIRECT ALERTS TO REDUCE TIME FROM EVENT TO CLINICAL DECISION. (REACT Study)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The sufficiency of the device data retrieved through the Remote Monitoring feature to make a clinical decision [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The physician or delegate time required for remote follow up as compared to in-clinic follow up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • The changes over one year in the Hospital Anxiety and Depression Scale (HADS) for the two different randomization arms [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Direct Alerts ON
Direct Alerts in implantable device were turned on
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
Active Comparator: Direct Alerts OFF
Direct Alerts in implantable device were turned off
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090349

Locations
Germany
Dr. Ralph Bosch
Ludwigsburg, Germany
United Kingdom
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01090349     History of Changes
Other Study ID Numbers: CR-09-064-WW-RC
Study First Received: March 18, 2010
Last Updated: September 24, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by St. Jude Medical:
ICD, CRTD, Remote Care

ClinicalTrials.gov processed this record on October 19, 2014