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).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- 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.