Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy

Objective: To evaluate the feasibility, acute, and three-month efficacy and safety of near-zero fluoroscopy PVI performed with the Farapulse system (Faravawe catheter, Faradrive sheath, Faraview module).

Primary hypothesis: High durability of PVI is achievable with minimal fluoroscopy PVI, using ICE-guided transseptal puncture and Farapulse system.

Study Design: Single-center, prospective, single-arm study. Investigator-initiated study.

Research period, expected enrollment rate: The planned research period starts in the third quarter of 2024. The expected enrollment rate is 4 patients/week. The enrollment and performance of the index procedure are expected to be completed within 1.5 - 2 months, and then three more months are required before the remap procedure.

Procedure: Standard PVI using Farapulse system and Faraview module. Follow-up: Invasive left atrial remap 3 months after the procedure. Imaging: CT and MRi scans to detect pulsed-field ablation scars before the FU procedure.

Endpoints:

• Primary endpoint: PVI durability at three months, detected by invasive left atrial remap, on a per PV basis.

• Secondary endpoints:

  • Continuity and size of the scar caused by the index ablation, detected on the cardiac MRI and CT before the remap (to compare it with the remapping data)
  • Door-to-door time (total time spent in the EP lab)
  • Skin-to-skin procedure time: time from the first femoral vein puncture to the removal of all sheaths
  • Left atrial dwelling time: time from inserting the long sheath in the left atrium to the sheath removal from the left atrium
  • Ablation time: time from the first until the last ablation
  • Fluoroscopy time and dose
  • Occurrence of any adverse events related to the procedure during the hospital stay at the 3 months remap the procedure