Atrial Fibrillation (AF)
Conditions
Brief summary
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.
Interventions
None listed
Sponsors
CathVision ApS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation. Male or non-pregnant female aged ≥18 years. Able and willing to provide written informed consent prior to any clinical investigation related procedure
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 is less than 12 months, in the opinion of the investigator * Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFAnalyzer output | From enrollment to hospital discharge typically 1 day | The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals. |
Countries
Croatia
Outcome results
None listed