ADVANTAGE AF

• Research type

  Research Study

• Full title

  A Prospective Single Arm Open Label Pivotal Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation

• IRAS ID

  317582

• Contact name

  Camille Metzdorff

• Contact email

  EUCLINICALS@bsci.com

• Sponsor organisation

  Boston Scientific International S.A

• Clinicaltrials.gov Identifier

  NCT05443594

• Duration of Study in the UK

  1 years, 5 months, 31 days

• Research summary

  The ADVANTAGE AF study is an investigational device study evaluating the safety and effectiveness of the FARAPULSE Pulsed Field Ablation system which uses pulsed electric energy for the treatment of symptomatic Persistent Atrial Fibrillation (PersAF).

  The ablation procedure for the treatment of PersAF requires an ablation procedure to be performed in the left atrium of the heart. The ablation procedure will use the FARAPULSE Pulsed Field Ablation System that consists of the following devices and components:
  • FARAWAVE™ Pulsed Field Ablation (PFA) Catheter
  • FARASTAR™ Catheter Connection Cable
  • FARASTAR™ Pulsed Field Ablation (PFA) Generator and associated cables
  • FARASTAR™ Recording System Module and associated cables
  • FARADRIVE™ Steerable Sheath

  The FARAWAVE Catheter will be used to create scar tissue around the pulmonary veins, on the back of the left upper chamber, the posterior wall, and the cavotricuspid isthmus is ablated with a commercially available radiofrequency ablation catheter, if warranted.

  Study data will be collected at visits before the procedure (pre-discharge), during the procedure and after the ablation procedure at follow-up visits Day 7, Day 30, Day 90, Day 180 and Day 360. Participation in the study will be complete approximately 12 months after the ablation procedure.

  This is a global, multi-center study that will recruit approximately 417 patients (up to 159
  Roll-In Subjects and approximately 258 Treatment Subjects) from up to 53 clinical sites, which may include North America, Europe, and Canada.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  23/LO/0299

• Date of REC Opinion

  13 Jun 2023

• REC opinion

  Further Information Favourable Opinion