Feasibility Study of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) System in the Treatment of Persistent Atrial Fibrillation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years of age, or older if required by local law
• Symptomatic, documented, Persistent AF or Paroxysmal AF
• Willing and capable of providing informed consent
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
Locations
Other Locations
Croatia
Klinicki bolnicki centar Split
RECRUITING
Split
Contact Information
Primary
Sharda Mehta
sharda.mehta@bsci.com
800-227-3422
Backup
Maria Grazia Pietropaolo
MariaGrazia.Pietropaolo@bsci.com
+393463514999
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 250
Treatments
Other: Catheter ablation for Persistent Atrial Fibrillation or Paroxysmal Atrial Fibrillation
200 subjects scheduled to undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with FARAFLEX mapping PFA catheter and other BSC devices.~Approximately 50 subjects meeting study eligibility requirements will be enrolled in a commercial sub-study at a subset of centers and will undergo endocardial mapping and ablation in the treatment of persistent atrial fibrillation or paroxysmal atrial fibrillation with a commercially approved PFA systems.
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation