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Trial record 1 of 13 for:    MORE-CARE
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MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)

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: NCT00885677
Recruitment Status : Terminated (Low enrollment rate)
First Posted : April 22, 2009
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Description
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Brief Summary:

The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices

  1. Remote monitoring with CareLink Network System
  2. Standard management of the disease by means of scheduled routine in-patient follow-ups;

and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Medtronic CareLink® Network Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 918 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MOnitoring REsynchronization deviCes and cARdiac patiEnts
Study Start Date : June 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study Group
Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.
 Device: Medtronic CareLink® Network

Continuous monitoring via a disease remote management system.

Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur.
No Intervention: Control Group
Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject. [ Time Frame: 1 year since the randomization ]
    The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group

  2. Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event [ Time Frame: 2 years after randomization ]
    Time to first event


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient indicated to CRT-ICD according to current guidelines:
  • Left ventricular systolic dysfunction (LVEF≤35%),
  • New York Heart Association functional class III-IV,
  • QRS≥120 ms
  • Optimized medical treatment.
  • Patient implanted within the last 8 weeks with Medtronic CRT-ICD device equipped with fluid accumulation diagnostics, AT/AF monitoring capability, wireless telemetry for automatic remote data transmission and alerting system for physician.
  • Patient with less than 8 weeks follow-up, who has not received Carelink® Network Monitor and was not managed by Cardiac Compass report reviewing.
  • Carelink Network is available at patient's home
  • Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties.
  • Patient is willing and able to sign an informed consent form.

Exclusion Criteria:

  • Inability to fully understand the instructions relating to remote monitoring using CareLink® Network.
  • Permanent AT/AF.
  • Patient had not been previously implanted with a CRT/CRT-D device.
  • Patient has medical conditions that would limit study participation.
  • Patient is less than 18 years of age.
  • Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints.
  • Patient meets any exclusion criteria required by local law.
  • Inability or refusal to sign a patient informed consent form.
  • Patient's life expectancy is less than one year in the opinion of the physician
  • Patient is pregnant or breastfeeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885677


Locations
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Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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Principal Investigator: Haran Burri, MD University Hospitals of Geneva Switzerland
Principal Investigator: Giuseppe Boriani, MD Policlinico Universitario Sant'Orsola, Bologna, Italy
Principal Investigator: Renato Pietro Ricci, MD Azienda Ospedaliera San Filippo Neri, Roma, Italy
Principal Investigator: Aurelio Quesada, MD Hospital General Universitario de Valencia, Spain
Principal Investigator: Stefano Favale, MD Policlinico Universitario di Bari, Italy
Principal Investigator: Josef Kautzner, MD IKEM, Prague, Czech Republic
Principal Investigator: Antoine Da Costa, MD Hopital du Nord, Saint Etienne, France
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00885677    
Other Study ID Numbers: MDT-MORE-CARE
First Posted: April 22, 2009    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases