Atrial Fibrillation
Conditions
Keywords
electrophysiology, cardiac ablation, persistent atrial fibrillation, cycle length
Brief summary
Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.
Detailed description
A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF. Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.
Interventions
Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation
Sponsors
CathVision ApS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent 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.
Exclusion criteria
* Current participation in another investigational drug or device study that interferes with 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 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, in the opinion of the Investigator. * Subjects who, in the opinion of the investigator, are not candidates for this study. * Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of AF Cycle Length | One day - day of procedure | Data collected during the study will be used to test an AF cycle length algorithm |
Countries
Belgium
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.29 years STANDARD_DEVIATION 9.12 |
| Diastolic Blood Pressure | 86.33 mmHg STANDARD_DEVIATION 12.59 |
| Heart Rate | 78.9 BPM STANDARD_DEVIATION 19.54 |
| Respiratory Rate | 16.52 breaths/min STANDARD_DEVIATION 2.62 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
| Systolic Blood Pressure | 138.48 mmHg STANDARD_DEVIATION 21.18 |
| Weight | 81.57 kg STANDARD_DEVIATION 17.71 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
None listed