CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
FARAPULSE™ Pulsed Field Ablation System Plusdevice
Likely dose
FARAPULSE™ Pulsed Field Ablation System Plus — specific ablation parameters not detailedAI-extracted
Key inclusion· 5
  • ✓Documented drug-resistant or intolerant persistent AF (refractory/intolerant to at least one Class I/III antiarrhythmic)
  • ✓First episode of persistent AF lasting 7-365 days
  • ✓Holter monitoring within 90 days showing 24 hours continuous AF
  • ✓Age 18-75 years at enrollment
Key exclusion· 17
  • ✕Paroxysmal AF (longest episode <7 days)
  • ✕Longstanding AF (persisted >12 months or unresponsive to cardioversion if <12 months)
  • ✕AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
  • ✕Left atrial anteroposterior diameter ≥5.5 cm

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05272852
NCT05272852N/ACompleted
CompareCT.gov

PersAFOne III: Feasibility Study of the FARAPULSE Pulsed Field Ablation System Plus - PersAF in the Treatment of Persistent Atrial Fibrillation

Boston Scientific Corporation·interventional·Posted Mar 10, 2022·Updated Jan 8, 2025

In Brief

A clinical study evaluating FARAPULSE™ Pulsed Field Ablation System Plus for Persistent Atrial Fibrillation. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Atrial Fibrillation
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 10, 2022
Enrollment StartFeb 3, 2022
Primary CompletionFeb 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.3 years ago

Interventions

FARAPULSE™ Pulsed Field Ablation System Plusdevice

Ablation using FARAPULSE™ Pulsed Field Ablation System Plus