Atrial FibrillationNCT05477602
The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
An observational study of Atrial Fibrillation, run by CathVision ApS at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation
- Keywords
- electrophysiology, cardiac ablation, persistent atrial fibrillation, cycle length
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Ablation for the treatment of persistent Atrial FibrillationProcedure or surgery
Also called Persistent AF Ablation
Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of AF Cycle Length
Data collected during the study will be used to test an AF cycle length algorithm
Measured: One day - day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start16 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathVision ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477602
- Sponsor's protocol ID
- CVAR-00002-A
- Status last verified
- Feb 2025
- First submitted
- 25 Jul 2022
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)
- ClinicalTrials.gov ID
- NCT05477602
- Acronym / sponsor ID
- CVAR-00002-A
- Conditions
- Atrial Fibrillation
- Keywords
- electrophysiology, cardiac ablation, persistent atrial fibrillation, cycle length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Ablation for the treatment of persistent Atrial FibrillationAlso: Persistent AF AblationPatients undergoing cardiac ablation for the treatment of persistent atrial fibrillation | Procedure or surgery | – |
Primary outcome
Measurement of AF Cycle Length
Time frame: One day - day of procedure
Data collected during the study will be used to test an AF cycle length algorithm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by CathVision ApS at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of AF Cycle Length (time frame: One day - day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 27 Oct 2026.