MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)
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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
- Remote monitoring with CareLink Network System
- 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 |
- 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 ]
- 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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Arnaldo Risi, PhD | +39-06-32814233 | arnaldo.risi@medtronic.com |
| Contact: Simona Falasca, MS | +39-06-32814266 | simona.falasca@medtronic.com |
Show 64 Study Locations| 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
Publications:
| Responsible Party: | Medtronic Bakken Research Center |
| ClinicalTrials.gov Identifier: | NCT00885677 History of Changes |
| Other Study ID Numbers: | MDT-MORE-CARE |
| Study First Received: | April 21, 2009 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013