Atrial Fibrillation ParoxysmalFACIL AFNCT05940597
Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
A study testing Pulse field ablation and Cryoballoon pulmonary vein isolation in people with Atrial Fibrillation Paroxysmal, run by University Hospital, Grenoble at 7 sites in France.
Trial summary
Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- Pulse field ablation and Cryoballoon pulmonary vein isolation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 7 sitesFrance
- Study dates
- 25 Sep 2023to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is of legal age to participate in the study (age >18 years)
- The patient is eligible for ablation of paroxysmal atrial fibrillation
- The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
- The patient is able and willing to return for required follow-up visits and examinations
Who cannot join
- Previous AF ablation
- Persistent and permanent AF
- The patient is contraindicated or allergic to oral anticoagulation
- The patient or legal representative is enable to understand and willing to provide written informed consent to participate in the trial
- The patient is enable and willing to return for required follow-up visits and examinations
- Pregnant or nursing patient
- Patient in exclusion period of another interventional study,
- Patient under administrative or judicial supervision
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Caen Normandie
Caen
Chu Grenoble Alpes
Grenoble, 38043
CHU Montpellier
Montpellier
Aphp / Hegp
Paris
CHU Rouen
Rouen
Clinique Pasteur
Toulouse
CHRU Tours
Tours
About this study
Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and different rates and types of complications. (2) The efficacy over a mean follow-up of one year with cryoablation for AF is comparable to that of radiofrequency ablation in a prospective randomized trial, with a lower major complication rate (3, 4). In recent years, AF cryoablation has established itself as a real alternative to RF ablation, to the point that this ablative source is chosen in one out of five European patients undergoing PV isolation. 70-80% of patients maintain sinus rhythm after a first procedure, showing an efficacy rate equivalent to ablation by RF. It is also comparable to RF when it comes to safety. Phrenic nerve palsy remains the major concern of cryoablation, accounting for 40% of periprocedural complications. A reduction in total procedure time and less dependence on the operator's experience make cryoablation an attractive choice for centres starting an AF ablation program. In conclusion, we do not yet have definitive data to affirm the superiority of one energy source over the other. Generally the choice depends on the availability of the centre and on the experience of the operator.
Pulse field ablation (PFA): Vivek Y. Reddy demonstrates that in patients with paroxysmal atrial fibrillation, PFA rapidly and efficiently isolates PVs with a degree of tissue selectivity and a safety profile(1).PFA can achieve a high degree of durable PV isolation with a comparable efficiency than another techniques (RF or CRYO) at one year follow-up (2) Cryoablation has been a recognised technique for the ablation of atrial fibrillation for many years, with many studies comparing the technique to radiofrequency ablation with equal results. Studies are underway to compare radiofrequency AF ablation versus PFA (BEAT-AF study). A randomized study to compare two methods of cryoablation versus PFA will be necessary to validate the non-inferiority of the technique.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- Pulse field ablation, Cryoballoon pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse field ablationDevice
ablation of paroxysmal atrial fibrillation by Pulse field ablation
Cryoballoon pulmonary vein isolationDevice
ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation arm | Active comparator | Market approved cryoablation system Receives: Device: Cryoballoon pulmonary vein isolation |
| PFA arm | Experimental | Market approved PFA ablation system (Farapulse - Boston Scientific system). Receives: Device: Pulse field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects experiencing one-year single-procedure clinical success
successful index of AF ablation, absence of atrial arrhythmia recurrence on any type of recording (30 sec by TTM (event monitor), holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), absence of use of class I or III AAD.
Measured: 12 months
Secondary outcomes (10)
Health-related quality of life
SF-12 questionnaire.
Measured: 6 and 12 months
Improvement in AF-specific quality of life
AFEQT questionnaire
Measured: 6 and 12 months
Proportion of patients with death
Death from any causes
Measured: 12 months
Proportion of patients with first hospitalization for cardiovascular causes.
First hospitalization for cardiovascular causes
Measured: 12 months
Proportion of patients with acute complication related to the procedure
tamponade, stroke, myocardial infarction, other
Measured: during the procedure or one day after
Total procedure duration
Procedure duration in minutes
Measured: during the procedure
Total time of fluoroscopy
Total time of fluoroscopy in minutes
Measured: during the procedure
Proportion of patients with embolic events from arrhythmia
Stroke
Measured: 12 months
Long term complications related to the procedure
phrenic palsy, pulmonary vein stenosis, pericarditis, other
Measured: 12 months
Recurrence of atrial fibrillation
Absence of atrial arrhythmia recurrence on any type of recording (30 sec by TTM (event monitor), holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), absence of use of class I or III AAD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start25 Sep 2023
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940597
- Sponsor's protocol ID
- 38RC23.0147
- Acronym
- FACIL AF
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05940597
- Acronym / sponsor ID
- FACIL AF / 38RC23.0147
- Conditions
- Atrial Fibrillation Paroxysmal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 11 Jul 2023 (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.
Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and different rates and types of complications. (2) The efficacy over a mean follow-up of one year with cryoablation for AF is comparable to that of radiofrequency ablation in a prospective randomized trial, with a lower major complication rate (3, 4). In recent years, AF cryoablation has established itself as a real alternative to RF ablation, to the point that this ablative source is chosen in one out of five European patients undergoing PV isolation. 70-80% of patients maintain sinus rhythm after a first procedure, showing an efficacy rate equivalent to ablation by RF. It is also comparable to RF when it comes to safety. Phrenic nerve palsy remains the major concern of cryoablation, accounting for 40% of periprocedural complications. A reduction in total procedure time and less dependence on the operator's experience make cryoablation an attractive choice for centres starting an AF ablation program. In conclusion, we do not yet have definitive data to affirm the superiority of one energy source over the other. Generally the choice depends on the availability of the centre and on the experience of the operator.
Pulse field ablation (PFA): Vivek Y. Reddy demonstrates that in patients with paroxysmal atrial fibrillation, PFA rapidly and efficiently isolates PVs with a degree of tissue selectivity and a safety profile(1).PFA can achieve a high degree of durable PV isolation with a comparable efficiency than another techniques (RF or CRYO) at one year follow-up (2) Cryoablation has been a recognised technique for the ablation of atrial fibrillation for many years, with many studies comparing the technique to radiofrequency ablation with equal results. Studies are underway to compare radiofrequency AF ablation versus PFA (BEAT-AF study). A randomized study to compare two methods of cryoablation versus PFA will be necessary to validate the non-inferiority of the technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation arm | Active comparator | Device: Cryoballoon pulmonary vein isolationMarket approved cryoablation system |
| PFA arm | Experimental | Device: Pulse field ablationMarket approved PFA ablation system (Farapulse - Boston Scientific system). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is of legal age to participate in the study (age >18 years)
- The patient is eligible for ablation of paroxysmal atrial fibrillation
- The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
- The patient is able and willing to return for required follow-up visits and examinations
Key exclusion criteria (8 listed)
- Previous AF ablation
- Persistent and permanent AF
- The patient is contraindicated or allergic to oral anticoagulation
- The patient or legal representative is enable to understand and willing to provide written informed consent to participate in the trial
- The patient is enable and willing to return for required follow-up visits and examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse field ablationablation of paroxysmal atrial fibrillation by Pulse field ablation | Device | PFA arm |
| Cryoballoon pulmonary vein isolationablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation | Device | Cryoablation arm |
Primary outcome
proportion of subjects experiencing one-year single-procedure clinical success
Time frame: 12 months
successful index of AF ablation, absence of atrial arrhythmia recurrence on any type of recording (30 sec by TTM (event monitor), holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), absence of use of class I or III AAD.
10 secondary outcomes
Health-related quality of life
Time frame: 6 and 12 months
Improvement in AF-specific quality of life
Time frame: 6 and 12 months
Proportion of patients with death
Time frame: 12 months
Proportion of patients with first hospitalization for cardiovascular causes.
Time frame: 12 months
Proportion of patients with acute complication related to the procedure
Time frame: during the procedure or one day after
Total procedure duration
Time frame: during the procedure
Total time of fluoroscopy
Time frame: during the procedure
Proportion of patients with embolic events from arrhythmia
Time frame: 12 months
Long term complications related to the procedure
Time frame: 12 months
Recurrence of atrial fibrillation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Atrial Fibrillation Paroxysmal
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal Atrial Fibrillation
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse field ablation and Cryoballoon pulmonary vein isolation in people with Atrial Fibrillation Paroxysmal, run by University Hospital, Grenoble at 7 sites 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of subjects experiencing one-year single-procedure clinical success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.