MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)
|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|
Show Detailed Description
|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
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|