Atrial Fibrillation (AF)MULTI PFANCT07379697
Measuring Local Potentials in PFA. MULTI PFA (EU)
An observational study of Atrial Fibrillation (AF), run by CathVision ApS.
Trial summary
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems. 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
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with atrial fibrillation referred for a cardiac ablation
Who may be able to join
- Subjects undergoing first time pulmonary vein isolation 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.
- Subjects in sinus rhythm at the time of the PFA application.
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.
- Subjects unlikely to be in sinus rhythm at the time of the procedure or unlikely to remain in sinus rhythm after cardioversion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Feasibility of Measuring Unipolar Atrial Local Potentials From a Range of Pulsed Field Ablation Catheters. The MULTI PFA (EU) Study
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems. The cohort will be adult patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using PFA.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a five-fold increase in stroke. Pulmonary vein isolation (PVI) has become a first-line treatment for paroxysmal AF. PVI is achieved by ablating cardiac tissue around the pulmonary veins. Until recently, this has been achieved using thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures. However, the catheters designed to deliver PFA differ to those used previously and do not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have successfully isolated the pulmonary vein. This exploratory observational study will assess the utility of a software module designed to measure the local potential derived from the unipolar electrogram recorded at the electrode that has delivered the PFA. During the procedure, the study will collect data only and all analysis of the output of the PFAnalyzer software module will be made off-line once the procedure is complete. The operator will follow the hospital's standard of care during the procedure, and the software module will not be used to guide therapy, nor will there be any additional time added to the procedure.
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect or VariPulse PFA systems. The cohort will be adult patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using PFA.
- Conditions
- Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a clinically meaningful threshold for residual potentials after PFA delivery
The peak-to-peak voltage in mV of post-PFA signals identified as local potentials by an experienced electrophysiologist will be recorded
Measured: At the time of the procedure
Identify a clinically meaningful threshold for residual potentials after PFA delivery
The peak-to-peak voltage of local potentials identified by an experienced electrophysiologist will be measured in mV by the PFAnalyzer software
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start28 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CathVision ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379697
- Sponsor's protocol ID
- CVPFA-004
- Acronym
- MULTI PFA
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Measuring Unipolar Atrial Local Potentials From a Range of Pulsed Field Ablation Catheters. The MULTI PFA (EU) Study
- ClinicalTrials.gov ID
- NCT07379697
- Acronym / sponsor ID
- MULTI PFA / CVPFA-004
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect, Volt or VariPulse PFA systems. The cohort will be adult patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using PFA.
Detailed description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a five-fold increase in stroke. Pulmonary vein isolation (PVI) has become a first-line treatment for paroxysmal AF. PVI is achieved by ablating cardiac tissue around the pulmonary veins. Until recently, this has been achieved using thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures. However, the catheters designed to deliver PFA differ to those used previously and do not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have successfully isolated the pulmonary vein. This exploratory observational study will assess the utility of a software module designed to measure the local potential derived from the unipolar electrogram recorded at the electrode that has delivered the PFA. During the procedure, the study will collect data only and all analysis of the output of the PFAnalyzer software module will be made off-line once the procedure is complete. The operator will follow the hospital's standard of care during the procedure, and the software module will not be used to guide therapy, nor will there be any additional time added to the procedure.
The study is a prospective, multi-center, exploratory, observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the Affera Sphere 9, FaraWave, PulseSelect or VariPulse PFA systems. The cohort will be adult patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using PFA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation referred for a cardiac ablation
Key inclusion criteria (4 listed)
- Subjects undergoing first time pulmonary vein isolation 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.
- Subjects in sinus rhythm at the time of the PFA application.
Key exclusion criteria (8 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
Identify a clinically meaningful threshold for residual potentials after PFA delivery
Time frame: At the time of the procedure
The peak-to-peak voltage in mV of post-PFA signals identified as local potentials by an experienced electrophysiologist will be recorded
Identify a clinically meaningful threshold for residual potentials after PFA delivery
Time frame: At the time of the procedure
The peak-to-peak voltage of local potentials identified by an experienced electrophysiologist will be measured in mV by the PFAnalyzer software
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by CathVision ApS.
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 8 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Firth, MSc (0702097102, kpf@cathvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify a clinically meaningful threshold for residual potentials after PFA delivery (time frame: At the time of the procedure). The study lists 2 primary outcomes in all. 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 17 Mar 2026.