MOnitoring REsynchronization deviCes and cARdiac patiEnts

NCT ID: NCT00885677

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 918 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2016-01-31

Brief Summary

The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices

1. Remote monitoring with CareLink Network System

2. 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.

Detailed Description

Major cardiovascular adverse events in patients with heart failure treated with cardiac resynchronization therapy (CRT-D) represent a big concern to the medical community, as they require hospitalizations and may lead to death.

Subjects with a history of heart failure are counseled regarding the importance of contacting their clinicians promptly if they experience any changes or worsening of their condition.

Acute heart failure episodes with hospitalizations represent one of the most relevant causes of health status deterioration for these patients. Moreover, atrial arrhythmias occurrence is a big issue, as it increases the risk of heart failure itself, stroke and inappropriate shocks. In addition to affecting patient health, hospital admission resulting from these complications will impact healthcare costs.

Latest generations of Medtronic CRT-D devices are equipped with a system that triggers an alarm if possible fluid accumulation is detected (OptiVol). This may initiate patient-clinician contact before evident cardiac decompensation. Moreover, advanced diagnostic capabilities for detecting atrial arrhythmias occurrence and total burden are available on such devices.

Importantly, all these devices are now able to inform physician of these events by remote monitoring with CareLink Network parameters, and have the potential of playing a key role in patient monitoring.

Over the last years, interest has been increasing in remote monitoring models for delivering care to HF patients, either as telemonitoring (transfer of physiological data through telephone or digital cable from home to healthcare provider) or as regular structured telephone contacts between patients and healthcare providers, which may or may not include data transfer.

Several studies with relatively large numbers of patients have been published (see table).

A recent meta-analysis found that remote monitoring programs for patients with chronic HF living in the community reduced admissions to hospital and all cause mortality by nearly one fifth while improving health related quality of life, but had no significant effect on all cause admission to hospital.

However, none of the published studies considered remote monitoring systems able to provide device-detected information on fluid accumulation, AT/AF total burden, arrhythmias occurrence and device-related issues in patients treated with CRT-D devices.

Early intervention may then be a key element in avoiding major cardiovascular events to occur and possible deterioration of the disease progression. The Carelink Network remote monitoring system, through Care Alerts, may initiate subject-clinician contact before typical signs and symptoms are exhibited, since it provides the physician with an automatic alert for atrial arrhythmias occurrence, fluid accumulation, and system integrity issues. However, clinical evidence must be provided of the superiority of this patient management strategy with respect to standard clinical practice, based on routine in-office visits.

Very recent findings showed that the use of CareLink in European clinical practice is technically feasible and that remote follow-up is an efficient method of surveillance of implanted patients. Moreover, the early detection and review of device and clinical events suggest the potential impact of remote monitoring on overall patient care.

There are a number of possible limitations with remote monitoring. The CareLink Network system requires that the patient establishes an initial contact between the device and the remote monitor unit, and that the unit is properly hooked up to the phone line. Not all patients may be able to perform the setup properly. There may be a delay by the physician in consulting patient data (for example over weekends), with a risk of adverse events occurring during that interval. There may be difficulties in contacting patients (e.g. if they are traveling). These possible limitations need to be properly assessed, especially for monitoring atrial arrhythmias, where the time factor is of importance for avoiding complications.

Remote patients' disease management has the potential for avoiding hospitalization. Clear demonstration that remote monitoring of AT/AF/HF plus strict treatment guidelines leads to a reduction in hospitalization rates has not been proven, and it could be a major argument for using this technology in routine clinical practice.

The MORE-CARE Study is aimed at comparing two different strategies of disease management in heart failure patients treated with CRT-D devices:

1. Remote disease management via Carelink Network system

2. Standard disease management by means of scheduled routine in-patient follow-ups. The main objective of the study is to demonstrate that the remote management strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Medtronic CareLink® Network

Intervention Type: DEVICE

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.

Control Group

Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haran Burri, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva Switzerland

Giuseppe Boriani, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Universitario Sant'Orsola, Bologna, Italy

Renato Pietro Ricci, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera San Filippo Neri, Roma, Italy

Aurelio Quesada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Valencia, Spain

Stefano Favale, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Universitario di Bari, Italy

Josef Kautzner, MD

Role: PRINCIPAL_INVESTIGATOR

IKEM, Prague, Czech Republic

Antoine Da Costa, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital du Nord, Saint Etienne, France

Locations

Institut Klinicke a Experimentalni Mediciny

Prague, , Czechia

Centre Hospitalier Universitaire de Angers

Angers, , France

Hôpital Cardiologique du Haut Lévêque

Bordeaux, , France

Centre Hospitalier

La Rochelle, , France

Hopital Louis Pradel

Lyon, , France

Hopital Saint Joseph

Marseille, , France

Hopital Arnaud de Villeneuve

Montpellier, , France

CHU

Narbonne, , France

Hopital La Source

Orléans, , France

Hopital La Pitie Salpetriere

Paris, , France

Clinique Bizet

Paris, , France

Hopital du Nord

Saint-Etienne, , France

CHRU

Tours, , France

Evaggelismos Hospital

Athens, , Greece

Henry Dynant Hospital - Athens

Athens, , Greece

University Hospital Herakleion

Heraklion, , Greece

HYGEIA - Hospital

Marousi, , Greece

University Hospital AHEPA Thessaloniki

Thessaloniki, , Greece

Gottsegen György Országos Kardiológia Intézet GOKI

Budapest, , Hungary

Semmelweis University AOK

Budapest, , Hungary

Wolfson Medical Center

Holon, , Israel

Ospedale Civile

Chioggia, Venezia, Italy

Ospedale Civile

Mirano, Venezia, Italy

Policlinico Universitario

Bari, , Italy

Cliniche Gavazzeni

Bergamo, , Italy

Ospedali Riuniti

Bergamo, , Italy

Policlinico Universitario S. Orsola-Malpighi

Bologna, , Italy

Fondazione Poliambulanza

Brescia, , Italy

Ospedale V.E. Ferrarotto

Catania, , Italy

Ospedale Pugliese e Ciaccio

Catanzaro, , Italy

Sant'Anna Hospital

Catanzaro, , Italy

Ospedale Unico della Versilia

Lido Di Camaiore (LU), , Italy

Centro Cardiologico Monzino

Milan, , Italy

Ospedale San Paolo

Milan, , Italy

A.O. Monaldi

Napoli, , Italy

Azienda Ospedaliera Sacro Cuore Don Calabria

Negrar, , Italy

Ospedale Giovan Battista Grassi

Ostia Antica, , Italy

Clinica San Carlo

Paderno Dugnano, , Italy

Ospedali Civico e Benfratelli

Palermo, , Italy

Ospedale San Salvatore

Pesaro, , Italy

Istituto di Fisiologia Clinica - CNR

Pisa, , Italy

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Azienda Complesso Ospedaliero San Filippo Neri

Roma, , Italy

Policlinico Tor Vergata

Roma, , Italy

Policlinico Umberto I

Roma, , Italy

Ospedale Santa Maria Del Carmine

Rovereto, , Italy

P.O. di Trento P.O.S.Chiara

Trento, , Italy

Azienda Ospedaliera-Ospedali Riuniti

Trieste, , Italy

Ospedale E. Macchi

Varese, , Italy

Ospedale Civile Maggiore di Borgo Trento

Verona, , Italy

MC Haaglanden - Locatie Westeinde

The Hague, , Netherlands

NUSCH

Bratislava, , Slovakia

VUSCH

Košice, , Slovakia

Hospital De Torrevieja

Alicante, , Spain

Hospital Reina Sofia

Córdoba, , Spain

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, , Spain

Hospital Universitario de Valme

Seville, , Spain

Hospital General Universitario

Valencia, , Spain

Hospital Universitario La Fé

Valencia, , Spain

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Universitätsspital

Basel, , Switzerland

University Hospital

Geneva, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Triemli Hospital

Zurich, , Switzerland

Countries

Czechia; France; Greece; Hungary; Israel; Italy; Netherlands; Slovakia; Spain; Switzerland

References

Burri H, Quesada A, Ricci RP, Boriani G, Davinelli M, Favale S, Da Costa A, Kautzner J, Moser R, Navarro X, Santini M. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Am Heart J. 2010 Jul;160(1):42-8. doi: 10.1016/j.ahj.2010.04.005.

Reference Type: BACKGROUND

PMID: 20598971 (View on PubMed)

Boriani G, Da Costa A, Ricci RP, Quesada A, Favale S, Iacopino S, Romeo F, Risi A, Mangoni di S Stefano L, Navarro X, Biffi M, Santini M, Burri H; MORE-CARE Investigators. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring. J Med Internet Res. 2013 Aug 21;15(8):e167. doi: 10.2196/jmir.2608.

Reference Type: RESULT

PMID: 23965236 (View on PubMed)

Burri H, da Costa A, Quesada A, Ricci RP, Favale S, Clementy N, Boscolo G, Villalobos FS, Mangoni di S Stefano L, Sharma V, Boriani G; MORE-CARE Investigators. Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator. Europace. 2018 May 1;20(5):e69-e77. doi: 10.1093/europace/eux206.

Reference Type: DERIVED

PMID: 28679168 (View on PubMed)

Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S Stefano L, Burri H; MORE-CARE Study Investigators. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2017 Mar;19(3):416-425. doi: 10.1002/ejhf.626. Epub 2016 Aug 28.

Reference Type: DERIVED

PMID: 27568392 (View on PubMed)

Other Identifiers

MDT-MORE-CARE

Identifier Type: -

Identifier Source: org_study_id