CompletedNot Applicable

The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

Belgium21 participantsStarted 2023-01-16

Plain-language 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.

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measurement of AF Cycle Length

Timeframe: One day - day of procedure

Trial details

NCT IDNCT05477602

SponsorCathVision ApS

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

Results submitted2026-01-14

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.