Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06510556 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Feasibility Study of the FARAFLEX Mapping and PFA System

Study acronym: ELEVATE-PF
StatusRecruiting
PhaseNot applicable
Started2025-02-17
View on ClinicalTrials.gov ↗

Amendment history

2026-08-26
2 amendments v22-v23
2 re-verifications since 2026-07-24, no change to tracked fields
2026-06-26
Study Status, Contacts/Locations v21
Study sitescontacts updated at 1 of 4 sites
2026-06-24
Study Status v20
Re-verified, no change to tracked fields
2026-05-28
Study Identification, Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v19
InterventionsCommercial Sub-study Treatment (Device), FARAFLEX Ablation Treatment (Device)→ELEVATE-COR Sub-study (Device), FARAFLEX Ablation Treatment (Device)
Eligibility criteria+857 characters
[...] ongenital methemoglobinemia History of known G6PD deficiency ELEVATE-COR (additional) Eligibility Criteria: Inclusion Criteria: Meets all inclusion criteria according to the ELEVATE-PF Protocol Planned for adjunctive CTI ablation Willing and capable of participating in all assessments and testing associated with this sub-study protocol. Exclusion Criteria: M [...]
Study sitescontacts updated at 1 of 4 sites
2026-05-26
Study Status v18
Re-verified, no change to tracked fields
Show 17 earlier versions
2026-04-29
Study Status, Contacts/Locations v17
Study sitescontacts updated at 4 of 4 sites
2026-03-26
Study Status v16
Re-verified, no change to tracked fields
2026-02-26
Study Status, Contacts/Locations v15
Study sites3→4
2026-01-27
2 amendments v13-v14
2 re-verifications since 2025-12-15, no change to tracked fields
2025-12-02
Study Status, Conditions, Study Design, Arms and Interventions, Eligibility v12
Study arms1→2
InterventionsAblation Treatment (Device)→Commercial Sub-study Treatment (Device), FARAFLEX Ablation Treatment (Device)
2025-11-21
Study Status, Contacts/Locations v11
Study sites2→3
2025-09-25
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v10
Primary completion date2025-12-15→2027-02-15
Completion date2026-12-15→2027-09-15
Enrollment target100→250
Eligibility criteria+1 characters
Inclusion Criteria: Age ≥ 18 years of age, or older if required by local law Symptomatic, documented, drug-resistant, Persistent AF or Paroxysmal AF Willing and capable of providing informed consent Willing a [...]
Study description+86 characters
[...] in the treatment of persistent Atrial Fibrillation (persAF) or Paroxysmal Atrial Fibrillation (PAF). Subjects with symptomatic Persistent Atrial Fibrillation or symptomatic Paroxysmal Atrial Fibrillation will be included in this study.
2025-08-11
3 amendments v7-v9
3 re-verifications since 2025-06-05, no change to tracked fields
2025-05-07
Study Identification, Study Status, Study Description v6
Study description-12 characters
The objective of this study is to obtain First-in-Human (FIH) experience with the FARFLEX PFAFARAFLEX mapping and ablation PFA catheter in the treatment of persistent Atrial Fibrilla [...]
Study titlerevised
Feasibility Study of the MAVERICKFARAFLEX Mapping and PFA System
2025-04-14
Study Status, Contacts/Locations v5
Study sites1→2
2025-03-25
Study Status v4
Re-verified, no change to tracked fields
2025-02-20
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-01-30
Study Status, Contacts/Locations v2
Completion date2025-12-15→2026-12-15
Start date2025-03-01→2025-02-17
2024-09-27
Study Identification, Study Status v1
Study title+12 characters
Feasibility Study of the MAVERICK Mapping and PFA System
2024-07-15
Original filing
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).
Trial Details
NCT Number NCT06510556
Lead Sponsor Boston Scientific Corporation
Conditions Atrial Fibrillation, Persistent Atrial Fibrillation, Paroxysmal AF
Enrollment 250 participants
Start Date 2025-02-17
Primary Completion 2027-02-15 (estimated)
Study Completion 2027-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-24