N/A
N=36
Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
Persistent Atrial Fibrillation · Cardiac Arrhythmia
Bottom Line
View on ClinicalTrials.gov: NCT05458648 ↗Enrolled (actual)
36
Serious AEs
2.9%
Results posted
Dec 2025
Primary outcome: Primary: Ability to Collect CS Data — 34 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- CathVision ApS
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability to Collect CS Data |
34 | — |
| SECONDARY Measurement of AF Cycle Length |
169.64 | — |
Summary
To acquire, amplify, digitize, and record atrial intracardiac electrophysiology signals during cardiac electrophysiology studies for the treatment of persistent atrial fibrillation and to use the recorded data to test the performance of an signal complexity visualization algorithm.
Eligibility Criteria
Inclusion Criteria
Eligible patients will meet all of the following inclusion criteria:
- Patients scheduled for RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
- Male or female ≥ 21 years of age.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure.
Exclusion Criteria
Eligible patients will not meet any of the following exclusion criteria:
- Current participation in another investigational drug or device study that interferes with this study.
- Patients who, in the opinion of the investigator, are not candidates for 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 patient'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.
- Patients who are considered part of any vulnerable population.
- Patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT05458648). 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.