Atrial Fibrillation (AF)NCT06877156
Local Potential Measurement In PFA: A Pilot Study
An observational study of Atrial Fibrillation (AF), run by CathVision ApS at 1 site in Croatia.
Trial summary
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 9 participants
- Where
- 1 siteCroatia
- Study dates
- 28 Jul 2025to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.
Who may be able to join
- Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.
- Male or non-pregnant female aged ≥18 years.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
Who cannot join
- Pregnant or nursing subjects.
- Current participation in another investigational drug or device study that interferes with this study.
- Subjects who, in the opinion of the investigator, are not candidates for this study.
- Patients who have had a prior ablation procedure
- 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 is less than 12 months, in the opinion of the investigator
- 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: Unipolar Signal Local Potential Measurement in Pulsed Field Ablation: A Pilot Study
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.
- Conditions
- Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| De Novo PFA ablation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFAnalyzer output
The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals.
Measured: From enrollment to hospital discharge typically 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start28 Jul 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- 9 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
- NCT06877156
- Sponsor's protocol ID
- CVPFA-001
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unipolar Signal Local Potential Measurement in Pulsed Field Ablation: A Pilot Study
- ClinicalTrials.gov ID
- NCT06877156
- Acronym / sponsor ID
- CVPFA-001
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| De Novo PFA ablation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.
Key inclusion criteria (3 listed)
- Subjects with paroxysmal or persistent atrial fibrillation (AF) undergoing first time PFA procedure indicated by investigator for the treatment of atrial fibrillation.
- Male or non-pregnant female aged ≥18 years.
- Able and willing to provide written informed consent prior to any clinical investigation related procedure
Key exclusion criteria (7 listed)
- Pregnant or nursing subjects.
- Current participation in another investigational drug or device study that interferes with this study.
- Subjects who, in the opinion of the investigator, are not candidates for this study.
- Patients who have had a prior ablation procedure
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFAnalyzer output
Time frame: From enrollment to hospital discharge typically 1 day
The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 (AF), run by CathVision ApS at 1 site in Croatia.
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 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 5 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 Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PFAnalyzer output (time frame: From enrollment to hospital discharge typically 1 day). 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 5 Dec 2025.