A simpler deep sedation approach for pulsed-field ablation in atrial fibrillation
Looks at a simpler sedation method during ablation for adults with atrial fibrillation.
Key facts
- Who runs it
- University Hospital, Caen
- Where
- Caen, FranceSee the site
- Trial code
- Registry title
- Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
- Status
- Enrolling by invitation
- People taking part
- 40 people, planned
- Started
- 1 Jun 2026
- Expected to end
- 12 Dec 2026
- Type of study
- Observational
- Record updated
- 8 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having a planned catheter ablation for atrial fibrillation using pulsed-field ablation (PFA).
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Atrial fibrillation, with a planned (elective) PFA-based catheter ablation.
Main reasons for not taking part
- Heart failure 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
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- elective PFA-based AF catheter ablation
Who cannot take part
- Obstructive sleep apnea syndrome, treated or untreated
- Chronic obstructive pulmonary disease or baseline SpO₂ < 95%
- Cognitive impairment and/or psychiatric disorders
- Heart failure classified as NYHA III or IV, or left ventricular ejection fraction < 40%
- Obesity with BMI > 35 kg/m²
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in France
- University Hospital CenterCaen, FranceNo longer taking part
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
- Plain-language title
- A simpler deep sedation approach for pulsed-field ablation in atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07633548, who can take part
- Record updated
- 8 June 2026