Pulsed-field AblationSAFE-PFANCT07633548
Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
An observational study of Pulsed-field Ablation and Deep Sedation, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulsed-field Ablation, Deep Sedation, Atrial Fibrillation (AF)
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 12 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for elective PFA-based AF catheter ablation.
Who may be able to join
- elective PFA-based AF catheter ablation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Keywords
- atrial fibrillation, catheter ablation, pulsed-field ablation, deep sedation, patient-reported outcomes, feasibility, safety
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-hour post-operative
Secondary outcomes (1)
Peroperative hypoventilation
Apnea > 60 seconds with SpO2 < 95% and/or use of bag-mask ventilation and/or conversion to mechanical ventilation (laryngeal mask or intubation).
Measured: Peroperative and up to 2-hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026
- Primary completion11 Nov 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulsed-field AblationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre OLLITRAULT, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633548
- Sponsor's protocol ID
- RYTHMO-2025-01
- Acronym
- SAFE-PFA
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40287932
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation
- ClinicalTrials.gov ID
- NCT07633548
- Acronym / sponsor ID
- SAFE-PFA / RYTHMO-2025-01
- Keywords
- atrial fibrillation, catheter ablation, pulsed-field ablation, deep sedation, patient-reported outcomes, feasibility, safety
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for elective PFA-based AF catheter ablation.
Key inclusion criteria (1 listed)
- elective PFA-based AF catheter ablation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Iowa Satisfaction with Anesthesia Scale (ISAS - French Version)
Time frame: 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.
1 secondary outcome
Peroperative hypoventilation
Time frame: Peroperative and up to 2-hour postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 40287932Sochorova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulsed-field Ablation and Deep Sedation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iowa Satisfaction with Anesthesia Scale (ISAS - French Version) (time frame: 3-hour post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.