Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
Condition(s) studied
Investigational drug(s) / intervention(s)
Pulmonary vein isolation ablation: Electrical isolation of the pulmonary veins to treat atrial fibrillation
Study 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.
Eligibility
Primary outcome measure(s)
- Pulmonary vein isolation — 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Trinity Health Ann Arbor Hospital | Ypsilanti | Michigan | Not Yet Recruiting |
| The Valley Hospital | Paramus | New Jersey | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07275151 on ClinicalTrials.gov ↗ ← All trials in the USA