NCT07633548Enrolling by invitation
Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 18 Nov 2025
- Start date
- 1 Jun 2026
- Primary completion date
- 11 Nov 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- Atrial fibrillation
- NCT number
- NCT07633548
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 Jun 2026 to the primary completion date, 11 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Obstructive sleep apnea syndrome, treated or untreated
- Chronic obstructive pulmonary disease or baseline SpO₂ \< 95%
- Cognitive impairment and/or psychiatric disorders
Lab values
- Heart failure classified as NYHA III or IV, or left ventricular ejection fraction \< 40%
Other
- Obesity with BMI \> 35 kg/m²
Who the study is looking for
- elective PFA-based AF catheter ablation
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Center Coordinator of this site? Confirm its status | Caen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.