Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
484actual
Sites
61
Countries
Australia, Austria, Belgium +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-28 | actual | When the study began enrolling |
| Primary completion | 2026-02-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-02-04 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Persistent Atrial Fibrillation
Interventions
- Device: FARAPULSE™ Pulsed Field Ablation (PFA) System
- Drug: Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
Primary outcomes
what the primary-completion date above is the date OFRate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.
measured 12-Months
Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.
measured 12-Months
Publications
- PMID 42041224 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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