Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA

NCT07275151 | Not Yet Recruiting

• 1 other identifier: CVPFA-002
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  intra-procedural

Secondary Outcomes (3)

• Clinical utility

  intra-procedural

• Identify a clinically meaningful threshold for residual potentials after PFA delivery.

  intra-procedural

• Feasibility of guiding rotation

  intra-procedural

Interventions

Pulmonary vein isolation ablation DEVICE

Electrical isolation of the pulmonary veins to treat atrial fibrillation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with paroxysmal atrial fibrillation and referred for a denovo pulmonary vein isolation ablation procedure using pulsed field ablation

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CathVision ApS: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suneet Mittal, MD

  Valley Health Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl P Firth, MSc

CONTACT

+45 31324745; kpf@cathvision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share