Health Technology/clinical-trials

Terminated Wearable Cardiac Monitoring Trial: Lessons from SimpleSense Validation Study for Right Heart Catheterisation

247 Health News Editorial

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12 Apr 2026

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4 min read

·clinical-trials

The SimpleSense wearable cardiac monitoring validation trial was terminated early with only 13 participants enrolled. This study aimed to validate algorithms for non-invasive cardiac output and pulmonary pressure estimation against right heart catheterisation.

Originally reported by ClinicalTrials.gov

References

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  2. 2.Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., Lijmer, J. G., Moher, D., Rennie, D., de Vet, H. C., Kressel, H. Y., Rifai, N., Golub, R. M., Altman, D. G., Hooft, L., Korevaar, D. A., & Cohen, J. F. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527. https://doi.org/10.1136/bmj.h5527
  3. 3.Galiè, N., Humbert, M., Vachiery, J. L., Gibbs, S., Lang, I., Torbicki, A., Simonneau, G., Peacock, A., Vonk Noordegraaf, A., Beghetti, M., Ghofrani, A., Gomez Sanchez, M. A., Hansmann, G., Klepetko, W., Lancellotti, P., Matucci, M., McDonagh, T., Pierard, L. A., Trindade, P. T., ... Hoeper, M. M. (2016). 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. European Heart Journal, 37(1), 67-119. https://doi.org/10.1093/eurheartj/ehv317
  4. 4.Nanowear Inc. (2024). The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure in Patients Undergoing Right Heart Catheterization. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05629533
  5. 5.Rudski, L. G., Lai, W. W., Afilalo, J., Hua, L., Handschumacher, M. D., Chandrasekaran, K., Solomon, S. D., Louie, E. K., & Schiller, N. B. (2010). Guidelines for the echocardiographic assessment of the right heart in adults. Journal of the American Society of Echocardiography, 23(7), 685-713. https://doi.org/10.1016/j.echo.2010.05.010
  6. 6.Therapeutic Goods Administration. (2023). Medical devices: Overview. Australian Government Department of Health. https://www.tga.gov.au/products/medical-devices
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247 Health News Editorial

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