Atrial FibrillationREFINE-PFANCT07275151
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
An observational study of Atrial Fibrillation, run by CathVision ApS at 2 sites in United States.
Trial summary
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation ablation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with paroxysmal atrial fibrillation and referred for a denovo pulmonary vein isolation ablation procedure using pulsed field ablation
Who may be able to join
- Eligible subjects will meet all of the following inclusion criteria:
- Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of 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.
- Subjects in sinus rhythm at the time of the PFA application.
Who cannot join
- Eligible subjects will not meet any of the following exclusion criteria:
- 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.
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- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Valley Hospital
Paramus, New Jersey, 07652
Dan Musat, MD, 201-432-7837, musada@valleyhealth.com
Jessica Mailim, RN
- Not yet recruiting
Trinity Health Ann Arbor Hospital
Ypsilanti, Michigan, 48197
Xu Gao, MD, 734-712-7787, Xu_Gao@michiganheart.com
Xu Gao, MD
About this study
Official title: Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation. REFINE-PFA
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
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 accepted treatment for AF. Historically, 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 may not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have durably 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, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation ablationDevice
Electrical isolation of the pulmonary veins to treat atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vein isolation
assess the agreement between pulmonary vein isolation status as determined by the operator using entrance block as well as exit block during PV pacing and as classified by the PFAnalyzer software based on unipolar local potential characteristics analyzed off-line, post procedure.
Measured: intra-procedural
Secondary outcomes (3)
Clinical utility
Assessment of the operators' subjective experience of clinical utility of the PFAnalyzer software measured through a 17-item questionnaire.
Measured: intra-procedural
Identify a clinically meaningful threshold for residual potentials after PFA delivery.
Identify a clinically meaningful threshold for residual potentials after PFA delivery by comparing the amplitude of manually expert labelled local potentials to none local potential signals.
Measured: intra-procedural
Feasibility of guiding rotation
Determine the feasibility of using PFAnalyzer to assist in optimizing rotation and placement of the catheter by measuring changes in local potential amplitude during rotation.
Measured: intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start22 Jul 2026
- Primary completion30 Nov 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 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
- 40 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
- NCT07275151
- Sponsor's protocol ID
- CVPFA-002
- Acronym
- REFINE-PFA
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation. REFINE-PFA
- ClinicalTrials.gov ID
- NCT07275151
- Acronym / sponsor ID
- REFINE-PFA / CVPFA-002
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 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.
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
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 accepted treatment for AF. Historically, 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 may not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have durably 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, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with paroxysmal atrial fibrillation and referred for a denovo pulmonary vein isolation ablation procedure using pulsed field ablation
Key inclusion criteria (5 listed)
- Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of 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.
- Subjects in sinus rhythm at the time of the PFA application.
Key exclusion criteria (9 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolation ablationElectrical isolation of the pulmonary veins to treat atrial fibrillation | Device | – |
Primary outcome
Pulmonary vein isolation
Time frame: intra-procedural
assess the agreement between pulmonary vein isolation status as determined by the operator using entrance block as well as exit block during PV pacing and as classified by the PFAnalyzer software based on unipolar local potential characteristics analyzed off-line, post procedure.
3 secondary outcomes
Clinical utility
Time frame: intra-procedural
Identify a clinically meaningful threshold for residual potentials after PFA delivery.
Time frame: intra-procedural
Feasibility of guiding rotation
Time frame: intra-procedural
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 21 Oct 2026.
- 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.
2 sites 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, run by CathVision ApS at 2 sites 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 P Firth, MSc (+45 31324745, kpf@cathvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vein isolation (time frame: intra-procedural). 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 21 Oct 2026.