NCT07633548

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

June 4, 2026

Conditions

Pulsed-field AblationDeep SedationAtrial Fibrillation (AF)

Keywords

atrial fibrillationcatheter ablationpulsed-field ablationdeep sedationpatient-reported outcomesfeasibilitysafety

Outcome Measures

Primary Outcomes (1)

  • Iowa Satisfaction with Anesthesia Scale (ISAS - French Version)

    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.

    3-hour post-operative

Secondary Outcomes (1)

  • Peroperative hypoventilation

    Peroperative and up to 2-hour postoperative

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted for elective PFA-based AF catheter ablation.

You may qualify if:

  • elective PFA-based AF catheter ablation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Center

Caen, 14000, France

Location

Related Publications (1)

  • 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: 40287932BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Pierre OLLITRAULT

Study Record Dates

First Submitted

November 18, 2025

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

December 12, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)