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Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF)

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Abstract

Background

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States.

Objective

MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland.

Methods and results

After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject’s 12-month visit.

Conclusions

The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems.

Trial registration

ClinicalTrials.gov; NCT02693691.

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Acknowledgements

Editing assistance was provided by Nicola Ryan, independent medical writer, funded by the University of Würzburg.

Funding

CEA designed the study in collaboration with the sponsor (St Jude Medical, subsequently acquired by Abbott, Sylmar, California, USA) and the steering committee. The sponsor provides funding including financial support for the qualification of up to two nurses per study site. In addition, trained sponsor personnel may perform on-site activities to ensure compliance to the clinical investigation plan, including expert support during and after the implant. Sponsor personnel do not perform the informed consent process, practice medicine, provide medical diagnosis or treatment to subjects, discuss a subject’s condition or treatment with a subject without the approval and presence of a healthcare practitioner, or independently collect clinical investigation data.

Author information

Authors and Affiliations

  1. Department of Medicine I, Cardiology, and Comprehensive Heart Failure Center Würzburg, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany

    Christiane E. Angermann & Georg Ertl

  2. University Hospital Frankfurt, Frankfurt, Germany

    Birgit Assmus

  3. Division of Cardiology and Metabolism and Department of Cardiology & Berlin-Brandenburg Center for Regenerative Therapies, and German Center for Cardiovascular Research, Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany

    Stefan D. Anker

  4. Department of Cardiology & Pneumology, University Medicine Göttingen (UMG), Göttingen, Germany

    Stefan D. Anker

  5. Regiomed Hospital Coburg, Coburg, Germany

    Johannes Brachmann

  6. Charité-Universitätsmedizin Campus Mitte, Berlin, Germany

    Friedrich Köhler

  7. University Hospital Cologne, Cologne, Germany

    Stephan Rosenkranz

  8. Charité-Universitätsmedizin Campus Virchow, Berlin, Germany

    Carsten Tschöpe

  9. Abbott, Austin, TX, USA

    Philip B. Adamson

  10. Saarland University Medical Center, Homburg, Germany

    Michael Böhm

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  1. Christiane E. Angermann
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Corresponding author

Correspondence to Christiane E. Angermann.

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Conflict of interest

Christiane E Angermann, Stefan D. Anker, Birgit Assmus, Johannes Brachmann, Georg Ertl, Friedrich Köhler, Stephan Rosenkranz, Carsten Tschöpe, and Michael Böhm serve at the steering committee of the MEMS-HF study. Dr Adamson is an employees and shareholder of Abbott. CEA is also a member of steering committees for trials sponsored by Novartis, ResMed, Vifor, and the CTSU Oxford and reports honoraria for consultancy and speaker fees from Abbott, Boehringer-Ingelheim, Medtronic, Novartis, ResMed, Servier, and Vifor; SDA reports honoraria for consultancy and speakers fees from Bayer, Boehringer Ingelheim, St. Jude Medical, Novartis, Servier, and Vifor; BA reports honoraria for consultancy and an unrestricted research grant from St Jude Medical, and speaker fees from Novartis, St Jude Medical and Vifor. MB reports honoraria for consultancy and speakers fees from Abbott, Astra-Zeneca, Bayer, Boehringer-Ingelheim, Cytogenetics, Medtronic, Servier, and Vifor. JB reports honoraria for consultancy and speakers fees and scientific support by Abbott, Medtronic and Biotronik; GE reports honoraria for consultancy and speakers fees from Bayer, Boehringer Ingelheim, St. Jude Medical, Novartis, Servier, and Vifor; FK reports research funding by the German Federal Ministry of Economics and Technology, the European Commission, and the German Federal Ministry of Education and Research; SR reports honoraria for consultancy, speaker fees, and scientific support by Abbott; SR has received remunerations for lectures and/or consultancy from Actelion, Bayer, BMS, MSD, Novartis, Pfizer, Vifor, and United Therapeutics, and his institution has received research grants from Actelion, Bayer, Novartis, and United Therapeutics; CT reports honoraria for consultancy and speakers fees from Abbott, and Novartis.

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Angermann, C.E., Assmus, B., Anker, S.D. et al. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol 107, 991–1002 (2018). https://doi.org/10.1007/s00392-018-1281-8

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