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

Overview

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.

Atrial fibrillation (AF) ablation improves symptoms and quality of life while reducing the risk of heart failure, ischemic stroke or transient ischemic attack, and cardiovascular mortality in appropriately selected patients. Pulsed-field ablation (PFA) is an effective and safe modality for AF ablation, based on selective electroporation of atrial myocardial cells using high-intensity, rapidly delivered electrical pulses. Consequently, PFA procedures most often require general anesthesia. In France, however, access to general anesthesia is limited for multiple reasons. It is therefore important to develop deep-sedation protocols (i.e., continuous ventilation without in-room anesthesiology support) in order to make PFA accessible to a larger number of patients. Existing protocols used in some European countries rely on restricted drugs reserved for anesthesiologists (e.g., propofol). The aim of this study is to demonstrate the feasibility and safety of a simplified deep-sedation protocol based on drugs that can be administered in the electrophysiology laboratory, with a specific focus on patient-reported outcomes.

Conditions

Eligibility

Locations (1)

Outcomes