Persistent Atrial FibrillationNCT05458648
Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
An observational study of Persistent Atrial Fibrillation and Cardiac Arrhythmia, run by CathVision ApS at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Cardiac Arrhythmia
- What is being tested?
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 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 already referred to undergo a cardiac ablation as treatment for persistent atrial fibrillation
Who may be able to join
- 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.
Who cannot join
- Eligible patients will not meet any of the following exclusion criteria:
- Current participation in another investigational drug or device study that interferes with this study.
- Patients who, in the opinion of the investigator, are not candidates for 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 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
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.
Read the detailed description
A prospective, single-center, pilot study using the CathVision ECGenius® system and the Ablation Impact Analyzer software in radiofrequency (RF) ablation procedures.
Subjects with persistent atrial fibrillation who are indicated to undergo an RF ablation to treat persistent AF may be enrolled in the Study.
Intracardiac signals will be passively recorded using the investigational ECGenius® System in parallel with the commercial (FDA Approved) EP Workmate, Abbott Inc. EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The CathVision ECGenius system allows physicians and users to record intracardiac electrograms during human electrophysiological studies including treatments for atrial fibrillation and atrial tachycardias. Improvements to the first-generation system are in development and include software features and algorithms for further analysis and description of signals to improve the clinical utility of the recorded signals. These new algorithms and software features require leveraging clinical use data as part of the development and iteration process.
This study will allow the evaluation of algorithms for advanced signal analysis in a low-risk clinical setting by recording raw electrocardiograms during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial tachycardias and atrial fibrillation. The data will be recorded by a conventional market-approved EP recording system and on a parallel investigational CathVision ECGenius system for subsequent offline prototype analysis. Information from the investigational system and algorithms will not be available to the physician during the treatment and will have no diagnostic or therapeutic impact on the clinical case.
The validation of the automated algorithm will be performed offline.
- Conditions
- Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Being tested
- Cardiac Ablation for the treatment of persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
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
Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Persistent AF Arm | Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation Receives: Procedure: 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.
Ability to Collect CS Data
Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.
Measured: One day - day of procedure
Secondary outcomes (1)
Measurement of AF Cycle Length
Data collected during the study will be used to test an AF cycle length algorithm
Measured: At the start of the procedure from the insertion of the CS catheter to the first ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start28 Jul 2022
- Primary completion30 Oct 2023
- 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 Persistent 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathVision ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Jacob, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458648
- Sponsor's protocol ID
- CVAR-00001-A
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2022
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
- ClinicalTrials.gov ID
- NCT05458648
- Acronym / sponsor ID
- CVAR-00001-A
- Conditions
- Persistent Atrial Fibrillation, Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, single-center, pilot study using the CathVision ECGenius® system and the Ablation Impact Analyzer software in radiofrequency (RF) ablation procedures.
Subjects with persistent atrial fibrillation who are indicated to undergo an RF ablation to treat persistent AF may be enrolled in the Study.
Intracardiac signals will be passively recorded using the investigational ECGenius® System in parallel with the commercial (FDA Approved) EP Workmate, Abbott Inc. EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The CathVision ECGenius system allows physicians and users to record intracardiac electrograms during human electrophysiological studies including treatments for atrial fibrillation and atrial tachycardias. Improvements to the first-generation system are in development and include software features and algorithms for further analysis and description of signals to improve the clinical utility of the recorded signals. These new algorithms and software features require leveraging clinical use data as part of the development and iteration process.
This study will allow the evaluation of algorithms for advanced signal analysis in a low-risk clinical setting by recording raw electrocardiograms during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial tachycardias and atrial fibrillation. The data will be recorded by a conventional market-approved EP recording system and on a parallel investigational CathVision ECGenius system for subsequent offline prototype analysis. Information from the investigational system and algorithms will not be available to the physician during the treatment and will have no diagnostic or therapeutic impact on the clinical case.
The validation of the automated algorithm will be performed offline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent AF Arm | – | Procedure: Cardiac Ablation for the treatment of persistent Atrial FibrillationPatients undergoing cardiac ablation for the treatment of persistent atrial fibrillation |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already referred to undergo a cardiac ablation as treatment for persistent atrial fibrillation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Current participation in another investigational drug or device study that interferes with this study.
- Patients who, in the opinion of the investigator, are not candidates for 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 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.
- Life expectancy less than 12 month, in the opinion of the Investigator.
- Patients who 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 FibrillationPatients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation. | Procedure or surgery | Persistent AF Arm |
Primary outcome
Ability to Collect CS Data
Time frame: One day - day of procedure
Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.
1 secondary outcome
Measurement of AF Cycle Length
Time frame: At the start of the procedure from the insertion of the CS catheter to the first ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- 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.
Larry Jacob, MD principal investigator
NYU Langone
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 Persistent Atrial Fibrillation and Cardiac Arrhythmia, run by CathVision ApS at 1 site in United States.
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 4 inclusion and 7 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 16 Dec 2025. 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 United States. 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 16 Dec 2025). 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?
Ability to Collect CS Data (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 16 Dec 2025.