N/A
Completed N=21
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
Source: ClinicalTrials.gov NCT05477602 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Jan 2026
Primary outcomePrimary: Measurement of AF Cycle Length — 171.64 ms
Summary
Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of AF Cycle Length |
171.64 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
- Male or non-pregnant female aged ≥ 21 years.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure.
Exclusion Criteria
- Current participation in another investigational drug or device study that interferes with this study.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 month, in the opinion of the Investigator.
- Subjects who, in the opinion of the investigator, are not candidates for this study.
- Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Data sourced from ClinicalTrials.gov (NCT05477602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.