ArticleJournal of cardiovascular electrophysiology2021
Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study.
Article in Journal of cardiovascular electrophysiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05450302 (To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection), which is not on this map. Cited by 1 paper.
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.
To Assess the Predictive Value of High Frequency Algorithm of PURE EP for Low Amplitude Signal Detection
Who cites it
1 citing paper in PubMed.
- Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study.Journal of cardiovascular electrophysiology · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades.
objectiveThe purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study.
methodsIntracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior.
resultsA total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p < .001). Only 14 PURE signals out of 218 were rated as Inferior (6.4%).
conclusionThe PURE intracardiac signals were statistically rated as superior when compared to conventional systems.
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Registered trials
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