NCT07275151 · CathVision ApS
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
(REFINE-PFA)
What this study is about
The study is a forward-looking, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The group of participants will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
View original scientific description
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.
Interventions
DEVICE
Pulmonary vein isolation ablation
Electrical isolation of the pulmonary veins to treat atrial fibrillation
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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
Where
- Ypsilanti, Michigan
- Paramus, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations