N/A
N=27
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Cardiac Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT05301803 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Sep 2024
Primary outcome: Primary: Baseline Noise Comparison — 19; 46; 31; 463 μV
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Electrophysiology procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CathVision ApS
- Primary completion
- Apr 2022
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 | — |
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.
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.