MOnitoring REsynchronization deviCes and cARdiac patiEnts (MORE-CARE)
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.
|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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885677
|Contact: Arnaldo Risi, PhDfirstname.lastname@example.org|
|Contact: Valentina Amori, MSemail@example.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|