N/A
N=101
Automated Assessment of PVI Using a Novel EP Recording System
Paroxysmal Atrial Fibrillation · Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05043883 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Aug 2024
Primary outcome: Primary: PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins. — 216; 215 Electrogram (EGM) — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CathVision Cube® system (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- CathVision ApS
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins. |
216; 215 | 0.006 sig |
| PRIMARY PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions. |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type. |
120; 95; 0; 107; 109; 0 | 0.00002 sig |
| SECONDARY Feasibility of "Real-time" Assessment of Isolation, Measured by Retesting the Accuracy of the PVI Analyzer Classification of Isolation Status at Different Timepoints Before, During and After Ablation. |
475 | 0.000005 sig |
| SECONDARY PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure |
25; 41 | 1 |
| SECONDARY Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation |
86 | 0.04 sig |
| SECONDARY Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used |
118; 127; 103; 124 | 0.0002 sig |
Summary
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
Eligibility Criteria
Eligible subjects will meet all of the following inclusion criteria:
- Subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of 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
Eligible subjects will not meet any of the following exclusion criteria:
- Pregnant or nursing subjects.
- Current participation in another investigational drug or device study that interferes with this Study.
- Subjects who, in the opinion of the investigator, are not candidates for this Study.
- Patients who have had a prior ablation procedure
- 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
- Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Data sourced from ClinicalTrials.gov (NCT05043883). 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.