Observational Study of Pulsed Field Ablation for Atrial Fibrillation

This study, called REFINE-PFA, is looking at a new way to treat atrial fibrillation (AF), a common heart rhythm problem. It focuses on a procedure called pulmonary vein isolation (PVI) using a newer method called pulsed field ablation (PFA). PFA uses short bursts of energy and is thought to be safer for nearby organs compared to older methods. Researchers will use a special software called PFAnalyzer with the ECGenius® System during PFA procedures to see how well it measures the electrical signals that show if the treatment worked. They want to see if this software can help doctors understand if the pulmonary veins are successfully isolated. You might be able to join if you are at least 21 years old, have atrial fibrillation, and are having PVI for the first time using the FaraPulse PFA system. The main goal is to see if the pulmonary veins are isolated during the procedure.

Study design
This is an observational study with 40 participants. It is designed to explore how a specific software works during a medical procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, pulmonary vein isolation, is measured during the procedure (intra-procedural).

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NCT07275151

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

Recruiting
Not specifiedAges 21+Observational
CathVision ApS
~40 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Pulmonary vein isolation ablation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulmonary vein isolation
Measured over intra-procedural
Atrial Fibrillation
2 sites across 2 states
Michigan1
New Jersey1

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  • Pulmonary vein isolationintra-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.