N/A
Completed N=27
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Cardiac Arrhythmia
Source: ClinicalTrials.gov NCT05301803 ↗
Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Sep 2024
Primary outcomePrimary: Baseline Noise Comparison — 19; 46; 31; 463 μV
Summary
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Noise Comparison |
19; 46; 31; 463 | — |
| PRIMARY Freedom From Major Adverse Events, Evaluated at Hospital Discharge |
26 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
- At least 18 years of age.
- Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).
Exclusion Criteria
- Patient inability to understand or refusal to sign informed consent.
- Patient is a prisoner or under incarceration
- Patients who in the opinion of the physician are not candidates for this study.
Data sourced from ClinicalTrials.gov (NCT05301803). 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.