Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
← catalyst calendarNCT07575269 · readout in 701 d
Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
571estimated
Sites
6
Countries
Ireland, United States
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 | 2026-07-07 | actual | When the study began enrolling |
| Primary completion | 2028-07-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-01-01 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Persistent Atrial Fibrillation
Intervention
- Device: FARAFLEX Mapping and Pulsed Field Ablation (PFA) System — also filed as FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter, FARAFLEX Catheter
Primary outcomes
what the primary-completion date above is the date OFProportion of Treatment Subjects and Attempt Subjects with device- or procedure-related defined Composite Serious Adverse Events, assessed through Day 60 following the index procedure.
measured After the index procedure, rescheduled index procedure, or first re-ablation performed with the FARAFLEX (Day 0) through Day 60
The primary effectiveness endpoint (PEE) is the proportion of Treatment Subjects with Treatment Success through the Day 365 Assessment.
measured Day 0 through the Day 365 Assessment
Permalink · BSX's whole pipeline · Catalyst calendar · Every registered study · What changed