Clinical Research Directory

Pulsed-field Ablation in Patients With Persistent Atrial Fibrillation

Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our project (The PIVCO study) aims to determine a more standardized procedure representing optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be associated with better effects in terms of rhythm control. Given the speed, safety, and ease of standardization of ablation using electroporation, a demonstration of the superiority of either approach could significantly impact the current standard of clinical care.

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

Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation

The aim of the SAFE-PFA study is to demonstrate the feasibility and safety of a simplified deep-sedation protocol for pulsed-field ablation of atrial fibrillation, with a specific focus on patient-reported outcomes.