Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulsed-field Ablation, Deep Sedation, Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Primary outcome measures
- Iowa Satisfaction with Anesthesia Scale (ISAS - French Version) [Time frame: 3-hour post-operative]
Secondary outcome measures (1)
- Peroperative hypoventilation [Time frame: Peroperative and up to 2-hour postoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University Hospital Center — Caen
Publications
- Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27. PMID 40287932
Identifiers
NCT: NCT07633548 · RYTHMO-2025-01