The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: Rationale and design

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Background

With the advent of remote monitoring, current models of implantable cardioverter defibrillators (ICDs) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload, atrial fibrillation and device integrity issues. Timely treatment of these events has the potential to improve patient outcome, but this has not as yet been proven.

Methods

The MORE-CARE study is a multicenter randomized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs. Up to 1720 patients with a standard indication for a biventricular ICD will be randomized to standard in-office follow-up, or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload, atrial fibrillation, and device integrity issues. The first phase aims at evaluating the delay between an alert event, and clinical action to the event. The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization. The duration of the study will be event-driven due to its sequential design.

Conclusion

MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD.

Section snippets

Methods

The study has been registered on www.clinicaltrials.gov under number NCT00885677.

Discussion

Advances in communication technology over the last years have been extended to the field of telemedicine and implantable devices. Remote follow-up of ICD patients by full device interrogation transmitted at scheduled intervals has gained widespread acceptance in the USA and is gaining popularity in Europe, where it has been more recently introduced. In a randomized controlled study of 1312 patients, remote device follow-up has been reported to be safe and has shown to reduce follow-up burden.16

Disclosures

Conflicts of interest: Mario Davinelli, Raymond Moser and Xavier Navarro are Medtronic employees. No other conflicts of interest exist.

Acknowledgements

We thank Mr Francesco de Seta, Mrs Alessandra Denaro, Mr Andrea Grammatico, Ms Tiziana De Santo, Mr Marco Vimercati, and Dr Sergio Valsecchi, (Medtronic Italy) for their help in setting up the study.

References (21)

  • CapucciA. et al.

    Monitored atrial fibrillation duration predicts arterial embolic events in patients suffering from bradycardia and atrial fibrillation implanted with antitachycardia pacemakers

    J Am Coll Cardiol

    (2005)
  • CrossleyG. et al.

    Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: the Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study

    Am Heart J

    (2008)
  • DicksteinK. et al.

    ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM)

    Eur Heart J

    (2008)
  • AbrahamW.T. et al.

    Cardiac resynchronization in chronic heart failure

    N Engl J Med

    (2002)
  • BristowM.R. et al.

    Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure

    N Engl J Med

    (2004)
  • ClelandJ.G. et al.

    Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase]

    Eur Heart J

    (2006)
  • YuC.M. et al.

    Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization

    Circulation

    (2005)
  • AbrahamW.T.

    Superior performance of intrathoracic impedance-derived fluid index versus daily weight monitoring in heart failure patients: results of the Fluid Accumulation Status Trial (FAST)

  • MainesM. et al.

    Usefulness of intrathoracic fluids accumulation monitoring with an implantable biventricular defibrillator in reducing hospitalizations in patients with heart failure: a case-control study

    J Interv Card Electrophysiol

    (2007)
  • PurerfellnerH. et al.

    Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies

    Pacing Clin Electrophysiol

    (2004)
There are more references available in the full text version of this article.

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