Atrial FibrillationFRANCE-PFANCT06497933
Exhaustive French National Registry of AF Ablation Using Pentaspline Pulsed Field Ablation Catheter
An observational study of Atrial Fibrillation, run by University Hospital, Rouen at 1 site in France.
Trial summary
Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- How many people
- 5,223 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Mar 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry
Who may be able to join
- Patients aged ≥18 years
- Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.
Who cannot join
- Previous left atrial ablation.
- Patient's opposition to participating in this registry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.
Read the detailed description
This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.
All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.
A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation
- Keywords
- Pulsed field ablation, registry
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Also called Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)
Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal atrial fibrillation patients | patients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter Receives: Procedure: Atrial fibrillation ablation | |
| Persistent atrial fibrillation patients | patients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter Receives: Procedure: Atrial fibrillation ablation | |
| Long-standing persistent atrial fibrillation patients | patients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter Receives: Procedure: Atrial fibrillation ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term efficacy (AA)
freedom from all types of atrial arrhythmia recurrences
Measured: within 1-year period post-procedure
very long-term efficacy (AA)
freedom from all types of atrial arrhythmia recurrences
Measured: Within 2 years period post-procedure
Secondary outcomes (3)
long term efficacy (AF)
freedom from atrial fibrillation recurrences
Measured: within 1-year period post-procedure
very long-term efficacy (AF)
freedom from atrial fibrillation recurrences
Measured: Within 2 years period post-procedure
Safety outcomes
the composite of major adverse events, including esophageal complications, symptomatic PV stenosis, cardiac tamponade requiring intervention, stroke or systemic thromboembolism, persistent phrenic nerve injury, vascular access complications requiring surgery, coronary artery spasm, and death
Measured: within 1-month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Mar 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 5,223 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic ANSELME, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497933
- Sponsor's protocol ID
- 2022/0259/OB
- Acronym
- FRANCE-PFA
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chaumont C, Laredo M, Thomas O, Maury P, Massoulie G, Defaye P, Boveda S, Marijon E, Escande W, Roux A, Raczka F, Guyomar Y, Jais P, Ollitrault P, Granier M, Fareh S, Marchand H, Pierre B, Abbey S, Noel A, Da Costa A, Extramiana F, Cesari O, Champ-Rigot L, Khoueiry Z, Villemin T, Traulle S, Treguer F, Bader H, Deharo JC, Degand B, Guy-Moyat B, Klug D, Gandjbakhch E, Zhao A, Beneyto M, Eschalier R, Venier S, Combes S, Lepillier A, Mielczarek M, Clementy N, Menet A, Sacher F, De Chillou C, Anselme F. Countrywide introduction of pulsed field ablation for the treatment of atrial fibrillation: Acute results from the FRANCE-PFA registry. Heart Rhythm O2. 2025 Apr 25;6(7):911-919. doi: 10.1016/j.hroo.2025.04.005. eCollection 2025 Jul.
PubMed 40734736
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaustive French National Online Registry of Atrial Fibrillation Ablation Procedures Using the Pentaspline Pulsed Field Ablation Catheter
- ClinicalTrials.gov ID
- NCT06497933
- Acronym / sponsor ID
- FRANCE-PFA / 2022/0259/OB
- Conditions
- Atrial Fibrillation
- Keywords
- Pulsed field ablation, registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,223 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 12 Jul 2024 (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.
Pulsed field ablation (PFA) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. As the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. This new ablation modality could increase the safety of pulmonary vein isolation (PVI) procedures compared to PVI using thermal energies. The investigators aim to provide the first exhaustive Nationwide registry using the pentaspline PFA catheter to treat atrial fibrillation patients.
Detailed description
This is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the Farapulse technology (Boston Scientific) since the start of this technology in France.
All patients treated with the Farapulse technology for atrial fibrillation in France from March 2021 to February 29th of 2024 will be included in the registry. The number of participating centers is 33.
A one-year and 2-year follow-up will be performed according to the standard practices of the different centers. The study duration will be 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal atrial fibrillation patients | – | Procedure: Atrial fibrillation ablationpatients with paroxysmal atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter |
| Persistent atrial fibrillation patients | – | Procedure: Atrial fibrillation ablationpatients with persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter |
| Long-standing persistent atrial fibrillation patients | – | Procedure: Atrial fibrillation ablationpatients with long-standing persistent atrial fibrillation undergoing first time catheter ablation using the pentaspline PFA catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent for the first time an atrial fibrillation ablation procedure, with pulmonary veins isolation performed with the pentaspline PFA catheter in France will be included in the registry
Key inclusion criteria (2 listed)
- Patients aged ≥18 years
- Patients who received catheter ablation for paroxysmal AF, persistent AF, or long-standing persistent AF.
Key exclusion criteria (2 listed)
- Previous left atrial ablation.
- Patient's opposition to participating in this registry
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 |
|---|---|---|
| Atrial fibrillation ablationAlso: Pulsed field ablation procedure using the Faradrive catheter (Boston Scientific)Pulmonary veins isolation potentially associated with other atrial lesions, performed with the pentaspline PFA catheter | Procedure or surgery | Long-standing persistent atrial fibrillation patients, Paroxysmal atrial fibrillation patients, Persistent atrial fibrillation patients |
Primary outcome
long-term efficacy (AA)
Time frame: within 1-year period post-procedure
freedom from all types of atrial arrhythmia recurrences
very long-term efficacy (AA)
Time frame: Within 2 years period post-procedure
freedom from all types of atrial arrhythmia recurrences
3 secondary outcomes
long term efficacy (AF)
Time frame: within 1-year period post-procedure
very long-term efficacy (AF)
Time frame: Within 2 years period post-procedure
Safety outcomes
Time frame: within 1-month post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 40734736Chaumont C, Laredo M, Thomas O, Maury P, Massoulie G, Defaye P, Boveda S, Marijon E, Escande W, Roux A, Raczka F, Guyomar Y, Jais P, Ollitrault P, Granier M, Fareh S, Marchand H, Pierre B, Abbey S, Noel A, Da Costa A, Extramiana F, Cesari O, Champ-Rigot L, Khoueiry Z, Villemin T, Traulle S, Treguer F, Bader H, Deharo JC, Degand B, Guy-Moyat B, Klug D, Gandjbakhch E, Zhao A, Beneyto M, Eschalier R, Venier S, Combes S, Lepillier A, Mielczarek M, Clementy N, Menet A, Sacher F, De Chillou C, Anselme F. Countrywide introduction of pulsed field ablation for the treatment of atrial fibrillation: Acute results from the FRANCE-PFA registry. Heart Rhythm O2. 2025 Apr 25;6(7):911-919. doi: 10.1016/j.hroo.2025.04.005. eCollection 2025 Jul.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Frederic ANSELME, MD, PhD principal investigator
University Hospital, Rouen
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 Atrial Fibrillation, run by University Hospital, Rouen 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. 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?
Results are not available in the source record.
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?
long-term efficacy (AA) (time frame: within 1-year period post-procedure). The study lists 2 primary outcomes in all. 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 NCT06497933, 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 19 Jul 2024.