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Enrolling By Invitation
NCT07633548
Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
Conditions: Pulsed-field Ablation, Deep Sedation, Atrial Fibrillation (AF)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 40
Sponsor: University Hospital, Caen
Location: University Hospital Center Caen
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* elective PFA-based AF catheter ablation
Exclusion Criteria:
* Heart failure classified as NYHA III or IV, or left ventricular ejection fraction \< 40%
* Obstructive sleep apnea syndrome, treated or untreated
* Obesity with BMI \> 35 kg/m²
* Chronic obstructive pulmonary disease or baseline SpO₂ \< 95%
* Cognitive impairment and/or psychiatric disorders
Source: ClinicalTrials.gov (NCT07633548). StuddyBuddy aggregates publicly available trial information.
