MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||918 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
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
|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|