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MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00885677
First received: April 21, 2009
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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 Intervention
Heart Failure
Device: Medtronic CareLink® Network

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: MOnitoring REsynchronization deviCes and cARdiac patiEnts

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Phase 1: mean time between event onset time and clinical decision for each subject. [ Time Frame: Phase 1: 2 years ] [ Designated as safety issue: No ]
  • Phase 2: death from any cause, cardiovascular and device-related hospitalizations (at least 48 hours stay). [ Time Frame: Phase 2: study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Costs of healthcare resources (including hospitalizations, exams, in-office visits and ED admissions) on a per subject basis. [ Time Frame: Phase 2: study end. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1721
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00885677

Contacts
Contact: Arnaldo Risi, PhD +39-06-32814233 arnaldo.risi@medtronic.com
Contact: Valentina Amori, MS +39-06-32814236 valentina.amori@medtronic.com

  Show 64 Study Locations
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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