Clinical Research Directory

Durability of Pulmonary Vein Isolation With Farapulse System Using Minimal Fluoroscopy

Sponsor: Semmelweis University

Summary

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

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