MOnitoring REsynchronization deviCes and cARdiac patiEnts

NCT00885677 | Terminated Results DMC

• 1 other identifier: MDT-MORE-CARE
• Study Type: interventional
• Target: 918
• Locations: 10 countries
• Sites: 64

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. 1.Remote monitoring with CareLink Network System
2. 2.Standard management of the disease by means of scheduled routine in-patient follow-ups;

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.

  The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group

  1 year since the randomization

• 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 to first event

  2 years after randomization

Study Arms (2)

Study Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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

Interventions

Medtronic CareLink® Network 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.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (64)

Institut Klinicke a Experimentalni Mediciny

Prague, Czechia

Location

Centre Hospitalier Universitaire de Angers

Angers, France

Location

Hôpital Cardiologique du Haut Lévêque

Bordeaux, France

Location

Centre Hospitalier

La Rochelle, France

Location

Hopital Louis Pradel

Lyon, France

Location

Hopital Saint Joseph

Marseille, France

Location

Hopital Arnaud de Villeneuve

Montpellier, France

Location

CHU

Narbonne, France

Location

Hopital La Source

Orléans, France

Location

Hopital La Pitie Salpetriere

Paris, 75651, France

Location

Clinique Bizet

Paris, France

Location

Hopital du Nord

Saint-Etienne, France

Location

CHRU

Tours, France

Location

Evaggelismos Hospital

Athens, 10676, Greece

Location

Henry Dynant Hospital - Athens

Athens, 11526, Greece

Location

University Hospital Herakleion

Heraklion, Greece

Location

HYGEIA - Hospital

Marousi, Greece

Location

University Hospital AHEPA Thessaloniki

Thessaloniki, 54636, Greece

Location

Gottsegen György Országos Kardiológia Intézet GOKI

Budapest, Hungary

Location

Semmelweis University AOK

Budapest, Hungary

Location

Wolfson Medical Center

Holon, Israel

Location

Ospedale Civile

Chioggia, Venezia, Italy

Location

Ospedale Civile

Mirano, Venezia, Italy

Location

Policlinico Universitario

Bari, Italy

Location

Cliniche Gavazzeni

Bergamo, Italy

Location

Ospedali Riuniti

Bergamo, Italy

Location

Policlinico Universitario S. Orsola-Malpighi

Bologna, Italy

Location

Fondazione Poliambulanza

Brescia, Italy

Location

Ospedale V.E. Ferrarotto

Catania, Italy

Location

Ospedale Pugliese e Ciaccio

Catanzaro, Italy

Location

Sant'Anna Hospital

Catanzaro, Italy

Location

Ospedale Unico della Versilia

Lido Di Camaiore (LU), Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Ospedale San Paolo

Milan, Italy

Location

A.O. Monaldi

Napoli, Italy

Location

Azienda Ospedaliera Sacro Cuore Don Calabria

Negrar, Italy

Location

Ospedale Giovan Battista Grassi

Ostia Antica, Italy

Location

Clinica San Carlo

Paderno Dugnano, Italy

Location

Ospedali Civico e Benfratelli

Palermo, Italy

Location

Ospedale San Salvatore

Pesaro, Italy

Location

Istituto di Fisiologia Clinica - CNR

Pisa, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, Italy

Location

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Ospedale Santa Maria Del Carmine

Rovereto, Italy

Location

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

Trento, Italy

Location

Azienda Ospedaliera-Ospedali Riuniti

Trieste, Italy

Location

Ospedale E. Macchi

Varese, Italy

Location

Ospedale Civile Maggiore di Borgo Trento

Verona, Italy

Location

MC Haaglanden - Locatie Westeinde

The Hague, Netherlands

Location

NUSCH

Bratislava, Slovakia

Location

VUSCH

Košice, Slovakia

Location

Hospital De Torrevieja

Alicante, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Location

Hospital Universitario de Valme

Seville, Spain

Location

Hospital General Universitario

Valencia, Spain

Location

Hospital Universitario La Fé

Valencia, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

Location

Universitätsspital

Basel, Switzerland

Location

University Hospital

Geneva, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

Triemli Hospital

Zurich, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 20598971 BACKGROUND

• 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.

  PMID: 23965236 RESULT

• 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.

  PMID: 28679168 DERIVED

• 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.

  PMID: 27568392 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Valentina Amori
• Organization: Medtronic EMEA RCC

valentina.amori@medtronic.com

3425417863

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: July 2, 2025
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

HU (2); SL (2); FR (12); CH (4); GR (5); CZ (1); IL (1); ES (7); IT (29); NL (1)