2026-08-26
notable
Study Status, Contacts/Locations v25
Enrollment closed, study ongoing
Study sitescontacts updated at 2 of 41 sites
2026-04-29
minor
Study Status, Contacts/Locations v21
Trial sites expanded: 34 → 39 locations
Show 20 earlier versions
2026-03-26
minor
Study Status, Study Design, Eligibility, Contacts/Locations v20
Enrollment target407→376
Study sites32→34
Eligibility criteria-41 characters
Inclusion Criteria:
≥ 18 years of age, or older if required by local law
Single previous endocardial AF ablation procedure for Paroxysmal Atrial Fibrillation (PAF) or PersistentPersAF AF (PersAF)that minimally included pulmonary vein isolation that occurred within 5 years prior to enrollment.
Documented (physician's note) diagnosis of PersAF either pr [...] of PersAF after the Index Procedure.
Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Pr [...] ersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after [...] [...]
2026-02-26
minor
Study Status, Contacts/Locations v19
2026-01-27
minor
Study Status, Contacts/Locations v18
2025-12-22
minor
Study Status, Contacts/Locations v17
2025-12-02
minor
Study Status, Contacts/Locations v16
2025-11-20
minor
Study Status, Contacts/Locations v15
2025-10-21
minor
Study Status, Contacts/Locations v14
2025-10-06
minor
Study Status, Contacts/Locations v13
2025-09-12
minor
Study Status, Contacts/Locations v12
2025-08-25
minor
Study Status, Contacts/Locations v11
2025-07-15
minor
2 amendments v9-v10
2 re-verifications since 2025-06-24, no change to tracked fields
2025-06-05
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03→2027-04
Start dateestimated 2025-05→confirmed 2025-06-03
Study sites0→1
2025-05-27
minor
Study Status v7
Re-verified, no change to tracked fields
2025-04-29
minor
Study Identification, Study Status v6
Study titlerevised
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, withWith the FARAPULSE Pulsed Field Ablation System
2025-03-20
minor
Study Identification, Study Status, Contacts/Locations v5
Primary completion date2027-06→2027-03
Completion date2028-10→2028-01
Start date2025-06→2025-05
Study titlerevised
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, Withwith the FARAPULSE Pulsed Field Ablation System
2025-03-18
minor
Study Identification, Study Status v4
Primary completion date2027-03→2027-06
Completion date2028-01→2028-10
Start date2025-03→2025-06
Study titlerevised
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, withWith the FARAPULSE Pulsed Field Ablation System
2025-02-27
minor
Study Status v3
Re-verified, no change to tracked fields
2025-01-29
minor
Study Status v2
Primary completion date2026-12→2027-03
Completion date2027-12→2028-01
Start date2024-12→2025-03
2024-12-17
minor
Study Identification, Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+921 characters
Inclusion Criteria:
≥ 18 years of age, or older if required by local law
Single previous AF ablation procedure for Paroxysmal Atrial Fibrillation (PAF) or Persistent AF (PersAF)that minimally included pulmonary vein isolation that occurred within 5 years prior to enrollment.
Documented (physician's note) diagnosis of PersAF within 180 dayseither prior to enrollmentthe subject's Index Procedure OR development of PersAF after the Index Procedure.
Documented evidence of AF recurrence at least 60 days after the subject's Index Procedure, captured by a recording from any regulatory cleared rhythm m [...] [...]
Primary endpoints2 entries, revised
The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.
Study titlerevised
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, Withwith the FARAPULSE Pulsed Field Ablation System