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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07633548

Acronym

SAFE-PFA

Enrollment

Registered

2026-06-08

Start date

2026-06-01

Completion date

2026-12-12

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Deep Sedation, Pulsed-field Ablation

Keywords

atrial fibrillation, catheter ablation, pulsed-field ablation, deep sedation, patient-reported outcomes, feasibility, safety

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Iowa Satisfaction with Anesthesia Scale (ISAS - French Version)	3-hour post-operative	The Iowa Satisfaction with Anesthesia Scale (ISAS) is a tool to assess the patient's satisfaction after sedation anesthesia. The French validated version will be used.

Secondary

Measure	Time frame	Description
Peroperative hypoventilation	Peroperative and up to 2-hour postoperative	Apnea \> 60 seconds with SpO2 \< 95% and/or use of bag-mask ventilation and/or conversion to mechanical ventilation (laryngeal mask or intubation).

Countries

France

Outcome results