Remote monitoring devices can detect early clinical decompensation of heart failure and possibly lead to improved patient outcomes, but this hypothesis is not yet supported by clinical trial data
Applying the rigorous methodology typical of clinical trials for therapeutic drugs and devices to establish the safety and effectiveness of diagnostic devices brings challenges that affect interpretation of completed trials
Bias and the extent to which protocols should mandate treatment in response to remote monitoring data are major challenges facing clinical research of remote monitoring devices
Blind adjudication of objective primary end points, identical follow-up between groups, and consistent guideline-directed treatment recommendations might help to mitigate challenges in future trials
Implantable monitoring devices have been developed to detect early evidence of heart failure (HF) decompensation, with the hypothesis that early detection might enable clinicians to commence therapy sooner than would otherwise be possible, and potentially to reduce the rate of hospitalization. In addition to the usual challenges inherent to device trials (such as the difficulty of double-blinding and potential for bias), studies of implantable monitoring devices present unique difficulties because they involve assessment of therapeutic end points for diagnostic devices. Problems include the lack of uniform approaches to treatment in study protocols for device alerts or out-of-range values, and the requirement of levels of evidence traditionally associated with therapeutic devices to establish effectiveness and safety. In this Review, the approaches used to deal with these issues are discussed, including the use of objective primary end points with blinded adjudication, identical duration of follow-up and number of encounters for patients in active monitoring and control groups, and treatment recommendations between groups that are consistent with international guidelines. Remote monitoring devices hold promise for reducing the rate of hospitalization among patients with HF. However, optimization of regulatory approaches and clinical trial design is needed to facilitate further evaluation of the effectiveness of combining health information technology and medical devices.
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This work was generated from discussions during the 9th Global Cardiovascular Clinical Trialists (CVCT) Forum held in Paris, France in December 2012. CVCT was organized by the Clinical Investigation Centre INSERM, CHU, and University Henri Poincaré of Nancy, France and funded by an unrestricted educational grant from Association de Recherche et d'Information en Cardiologie (ARISC), a nonprofit educational organization, in Nancy, France. ARISC had no involvement in the preparation, review, or approval of this manuscript for publication. The following individuals were panellists discussing the topic of this manuscript at the 9th Global CVCT Forum: T. Shipman (St. Jude Medical, Inc., MN, USA) D. Brutsaert (University of Antwerp, Belgium), R. Cody (Johnson & Johnson, Inc., NJ, USA), and B. Swynghedauw (Institut National de la Santé et de la Recherche Médicale [INSERM], France).
W.T.A. has acted as an advisor or consultant for Abbott Vascular, Biotronik, Cardiokinetix, CardioMEMS, Medtronic, St. Jude Medical, Respicardia, and Sunshine Heart. W.G.S. has acted as a consultant for Medtronic and has received financial travel support from INSERM. I.L.P. has acted as a consultant for and received salary support from the FDA. C.L. has acted as a consultant for and received speaker's fees and grants from Cardiomems, Medtronic, St. Jude Medical, and Respicardia. J.S.B. has acted as a consultant, committee member, advisory board member, and speaker for ARMGO, Biotronik, Cardiorentis, Cardioxyl, Celladon, JenaValve, Novartis, Pfizer, and Servier. G.M.D.F. has acted as a committee member, advisory board member, and speaker for Amgen, Boston Scientific, and Merck. R.M. has received research grants, and has acted as a consultant and advisory board member for Abbott Vascular, AstraZeneca, Boston Scientific, Bristol-Myers Squibb, Covidien, CSL Behring, Lilly/Daiichi Sankyo, Janssen Pharmaceuticals, Maya Medical, Merck, Regado Biosciences, Sanofi-Aventis, and The Medicines Company. K.S. is a shareholder in Boston Scientific. A.V. is a shareholder in Medtronic. J.S.Y. is a shareholder in CardioMEMS. S.D.A. has acted as a consultant, committee member, and advisory board member for BioVentrix, Bosch GmbH, CardioMems, Impulse Dynamics, Lonestar, and Medical Sensible. F.Z. has acted as committee member, founder, consultant, or advisory board member at Bayer, Boston Scientific, CardioMEMS, CardioRenal Diagnostics, Janssen, Novartis, Pfizer, Resmed, Servier, St. Jude Medical, and Takeda.
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Abraham, W., Stough, W., Piña, I. et al. Trials of implantable monitoring devices in heart failure: which design is optimal?. Nat Rev Cardiol 11, 576–585 (2014). https://doi.org/10.1038/nrcardio.2014.114
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