Trial reportBMC cardiovascular disorders2022
Changes in R-wave amplitude at implantation are associated with gender and orientation of insertable cardiac monitor: observations from the confirm Rx™ body posture and physical activity study.
Trial report in BMC cardiovascular disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03803969 (ConfirmRxTM), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
ConfirmRxTM: Effects of Patient Posture and Physical Activity
Who cites it
3 citing papers in PubMed, 3 citations in OpenAlex.
- Algorithm Improvements in an Insertable Cardiac Monitor Reduce False Positives and Episode Review Burden.Pacing and clinical electrophysiology : PACE · 2025Article
- Comparison of Electrocardiogram Characteristics of Two Commercially Available Implantable Loop Monitors: Impact of These Characteristics in the Correct Adjudication of Recorded Events and Minimized Undersensing and Oversensing of Events.The Journal of innovations in cardiac rhythm management · 2025Article
- "Real-world" performance of the Confirm Rx™ SharpSense AF detection algorithm: UK Confirm Rx study.Journal of arrhythmia · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInsertable cardiac monitors (ICMs) are small subcutaneously implanted devices that detect changes in R-wave amplitudes (RWAs), effective in arrhythmia-monitoring. Although ICMs have proven to be immensely successful, electrical artefacts are frequent and can lead to misdiagnosis. Thus, there is a growing need to sustain and increase efficacy in detection rates by gaining insight into various patient-specific factors such as body postures and activities.
methodsRWAs were measured in 15 separate postures, including supine, lying on the right-side (RS) or left-side (LS) and sitting, and two separate ICM orientations, immediately after implantation of Confirm Rx™ ICM in 99 patients.
resultsThe patients (53 females and 46 males, mean ages 66.62 ± 14.7 and 66.40 ± 12.25 years, respectively) had attenuated RWAs in RS, LS and sitting by ~ 26.4%, ~ 27.8% and ~ 21.2% respectively, compared to supine. Gender-based analysis indicated RWAs in RS (0.32 mV (0.09-1.03 mV), p < 0.0001) and LS (0.37 mV (0.11-1.03 mV), p = 0.004) to be significantly attenuated compared to supine (0.52 mV (0.20-1.03 mV) for female participants. Similar attenuation was not evident for male participants. Further, parasternally oriented ICMs (n = 44), attenuated RWAs in RS (0.37 mV(0.09-1.03 mV), p = 0.05) and LS (0.34 mV (0.11-1.03 mV), p = 0.02) compared to supine (0.48 mV (0.09-1.03 mV). Similar differences were not observed in participants with ICMs in the 45°-relative-to-sternum (n = 46) orientation. When assessing the combined effect of gender and ICM orientation, female participants demonstrated plausible attenuation in RWAs for RS and LS postures compared to supine, an effect not observed in male participants.
conclusionThis is the first known study depicting the effects on RWA due to body postures and activities immediately post-implantation with an overt impact by gender and orientation of ICM. Future work assessing the cause of gender-based differences in RWAs may be critical.
trial registrationClinical Trials, NCT03803969. Registered 15 January 2019 - Retrospectively registered, https://clinicaltrials.gov/NCT03803969.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.