MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)
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| ClinicalTrials.gov Identifier: NCT00885677 |
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Recruitment Status :
Terminated
(Low enrollment rate)
First Posted : April 22, 2009
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure | Device: Medtronic CareLink® Network | Not Applicable |
Show detailed description
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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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- 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
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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
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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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Heart Failure Heart Diseases Cardiovascular Diseases |