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NCT05458648Completed

Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

To acquire, amplify, digitize, and record atrial intracardiac electrophysiology signals during cardiac electrophysiology studies for the treatment of persistent atrial fibrillation and to use the recorded data to test the performance of an signal complexity visualization algorithm.

Status (registry)
Completed
Study type
Observational
Enrollment
37 (actual)
First submitted
17 Jun 2022
Start date
Jul 2022
Primary completion date
Oct 2023
Lead sponsor
CathVision ApS
NCT number
NCT05458648

What you commit to

  • Study type: Observational
  • Participants enrolled: 37
  • From Jul 2022 to the primary completion date, Oct 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current participation in another investigational drug or device study that interferes with this study.

Other illness

  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient'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.

Other

  • Eligible patients will not meet any of the following exclusion criteria:
  • Patients who, in the opinion of the investigator, are not candidates for this study.
  • Life expectancy less than 12 month, in the opinion of the Investigator.
  • Patients who are considered part of any vulnerable population.
  • Patient is a prisoner.

Who the study is looking for

  • Eligible patients will meet all of the following inclusion criteria:
  • Patients scheduled for RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
  • Male or female ≥ 21 years of age.
  • Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.