Atrial FibrillationRIPAF-2NCT06160076
Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation-2
An observational study of Atrial Fibrillation and Catheter Ablation, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Catheter ablation using pulmonary vein isolation (PVI) in an established treatment strategy for AF. Pulsed Field Ablation (PFA) is a non-thermal ablation modality which has recently been introduced in clinical practice with the aim of improving… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation, Inflammation
- What is being tested?
- Radiofrequency and Pulsed electric field
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2023to 25 Apr 2025
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation treated by catheter ablation
Who may be able to join
- Age ≥ 18 years
- Patients with paroxysmal AF referred for first-time catheter ablation using PFA or RFA
- Non-opposition to participate
Who cannot join
- Age < 18 years
- Persons under judicial protection (guardianship, guardianship) or deprived of freedom
- Prior left atrial ablation
- Prior cardiac surgery comprising incision of the left atrium
- Prior myocardial infarction or stroke in the previous 30 days
- Acute or chronic inflammatory state: active smoking, auto-immune disease, active tumor disease, myocarditis
- Antiplatelet therapy (e.g. aspirine, clopidogrel) within the 7 last days
- Anti-inflammatory treatment (e.g. glucocorticoids, colchicine, cyclophosphamide, azathioprine, mycophenolic acid, antibodies) within the 7 last days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Catheter ablation using pulmonary vein isolation (PVI) in an established treatment strategy for AF. Pulsed Field Ablation (PFA) is a non-thermal ablation modality which has recently been introduced in clinical practice with the aim of improving PVI efficacy and safety. The aim of this study is to analyse whether PFA generates a lower inflammatory reaction as compared to conventional radiofrequency ablation (RFA).
Read the detailed description
Pulmonary vein isolation represents the cornerstone of AF ablation. PFA is a novel non-thermal cardiac ablation modality which is currently studied in clinical trials for the treatment of AF with promising efficacy and safety results. PFA is reported to generate less collateral damage by inducing selective apoptosis of cardiomyocytes, while other structures such as nerves, vessels and oesophageal tissue remain spared. PFA lesions show more organized and homogeneous fibrosis on histopathological study as compared to thermal lesions. In a recent study conducted at Hôpital Haut-Lévêque, PFA was associated with 20% less acute oedema on magnetic resonance imaging. Therefore, PFA may generate a reduced inflammatory reaction which could translate into lower early recurrence rates, less post-procedural chest pain and improved clinical outcomes. Data on the systemic inflammation generated by PFA and RFA is still lacking.
The aim of this study is to analyse the inflammatory reaction after PFA and RFA in patients referred for first-time catheter ablation of paroxysmal AF. For this purpose, established biomarkers of systemic inflammation (leucocytosis, platelet-monocyte-complexes, inflammatory cytokines) will be determined in blood samples collected from patients treated with either PFA or RFA.
The collection of blood samples will be exclusively performed during routine blood drawing at three time points: at the beginning of the procedure (to define baseline values), at the end of the procedure (to measure acute inflammation) and the day following the procedure (to define inflammation occurring within 24 hours). Clinical signs of inflammation (fever, chest pain, pericardial fluid) and early arrhythmia recurrences will also be assessed the day after the ablation. On a routine 6-month follow-up visit, late arrhythmia recurrences will be registered. In a secondary analysis, the thrombogenic and pro-arrhythmogenic potential of both ablation modalities and the predictive value of inflammatory biomarkers for early and late recurrences will be assessed.
- Conditions
- Atrial Fibrillation, Catheter Ablation, Inflammation
- Being tested
- Radiofrequency, Pulsed electric field
- Keywords
- Atrial Fibrillation, catheter ablation, Inflammation, Pulsed-field ablation
- Medical subject headings
- Atrial Fibrillation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
Also called Catheter ablation per radiofrequency
Patient with atrial fibrillation ablated per catheter using radiofrequency energy
Pulsed electric fieldDevice
Also called Catheter ablation per pulsed electric field
Patient with atrial fibrillation ablated per catheter using pulsed electric field
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Patient with atrial fibrillation ablated per radiofrequency Receives: Device: Radiofrequency | |
| Pulsed electric field | Patient with atrial fibrillation ablated per pulsed electric field Receives: Device: Pulsed electric field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute thromboinflammatory response
Circulating platelet-monocyte complexes (PMC)
Measured: 24 hours
Systemic inflammatory response (IL-6)
Changes in leukocyte count and circulating levels of IL-6
Measured: 24 hours
Systemic inflammatory response (TNF-α)
Changes in leukocyte count and circulating levels of TNF-α
Measured: 24 hours
Systemic inflammatory response (CRP)
Changes in leukocyte count and circulating levels of CRP
Measured: 24 hours
Pericarditis
Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)
Measured: 24 hours
Secondary outcomes (4)
Incidence of early arrhythmias
Incidence of early arrhythmias occurring during the post-operative period on telemetry in PFA vs. RFA
Measured: 24 hours
Analysis of biomarkers (CD40L)
Platelet activation: Changes in plasma levels of soluble CD40L
Measured: 24 hours
Analysis of biomarkers (Willebrand)
Endothelial cell damage: Changes in plasma levels of von Willebrand factor
Measured: 24 hours
Incidence of late atrial arrhythmia recurrence
Atrial fibrillation and/or atrial tachycardia recurrences documented by Holter-ECGs or other wearable devices
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start16 Oct 2023
- Primary completion11 Oct 2024
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre JAÏS, MD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160076
- Sponsor's protocol ID
- CHUBX 2023/33
- Acronym
- RIPAF-2
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2023
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response Following " Pulsed Field Ablation " vs. Radiofrequency Ablation of Paroxysmal Atrial Fibrillation-2
- ClinicalTrials.gov ID
- NCT06160076
- Acronym / sponsor ID
- RIPAF-2 / CHUBX 2023/33
- Conditions
- Atrial Fibrillation, Catheter Ablation, Inflammation
- Keywords
- Atrial Fibrillation, catheter ablation, Inflammation, Pulsed-field ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 7 Dec 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.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Catheter ablation using pulmonary vein isolation (PVI) in an established treatment strategy for AF. Pulsed Field Ablation (PFA) is a non-thermal ablation modality which has recently been introduced in clinical practice with the aim of improving PVI efficacy and safety. The aim of this study is to analyse whether PFA generates a lower inflammatory reaction as compared to conventional radiofrequency ablation (RFA).
Detailed description
Pulmonary vein isolation represents the cornerstone of AF ablation. PFA is a novel non-thermal cardiac ablation modality which is currently studied in clinical trials for the treatment of AF with promising efficacy and safety results. PFA is reported to generate less collateral damage by inducing selective apoptosis of cardiomyocytes, while other structures such as nerves, vessels and oesophageal tissue remain spared. PFA lesions show more organized and homogeneous fibrosis on histopathological study as compared to thermal lesions. In a recent study conducted at Hôpital Haut-Lévêque, PFA was associated with 20% less acute oedema on magnetic resonance imaging. Therefore, PFA may generate a reduced inflammatory reaction which could translate into lower early recurrence rates, less post-procedural chest pain and improved clinical outcomes. Data on the systemic inflammation generated by PFA and RFA is still lacking.
The aim of this study is to analyse the inflammatory reaction after PFA and RFA in patients referred for first-time catheter ablation of paroxysmal AF. For this purpose, established biomarkers of systemic inflammation (leucocytosis, platelet-monocyte-complexes, inflammatory cytokines) will be determined in blood samples collected from patients treated with either PFA or RFA.
The collection of blood samples will be exclusively performed during routine blood drawing at three time points: at the beginning of the procedure (to define baseline values), at the end of the procedure (to measure acute inflammation) and the day following the procedure (to define inflammation occurring within 24 hours). Clinical signs of inflammation (fever, chest pain, pericardial fluid) and early arrhythmia recurrences will also be assessed the day after the ablation. On a routine 6-month follow-up visit, late arrhythmia recurrences will be registered. In a secondary analysis, the thrombogenic and pro-arrhythmogenic potential of both ablation modalities and the predictive value of inflammatory biomarkers for early and late recurrences will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | – | Device: RadiofrequencyPatient with atrial fibrillation ablated per radiofrequency |
| Pulsed electric field | – | Device: Pulsed electric fieldPatient with atrial fibrillation ablated per pulsed electric field |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation treated by catheter ablation
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with paroxysmal AF referred for first-time catheter ablation using PFA or RFA
- Non-opposition to participate
Key exclusion criteria (8 listed)
- Age < 18 years
- Persons under judicial protection (guardianship, guardianship) or deprived of freedom
- Prior left atrial ablation
- Prior cardiac surgery comprising incision of the left atrium
- Prior myocardial infarction or stroke in the previous 30 days
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 |
|---|---|---|
| RadiofrequencyAlso: Catheter ablation per radiofrequencyPatient with atrial fibrillation ablated per catheter using radiofrequency energy | Device | Radiofrequency |
| Pulsed electric fieldAlso: Catheter ablation per pulsed electric fieldPatient with atrial fibrillation ablated per catheter using pulsed electric field | Device | Pulsed electric field |
Primary outcome
Acute thromboinflammatory response
Time frame: 24 hours
Circulating platelet-monocyte complexes (PMC)
Systemic inflammatory response (IL-6)
Time frame: 24 hours
Changes in leukocyte count and circulating levels of IL-6
Systemic inflammatory response (TNF-α)
Time frame: 24 hours
Changes in leukocyte count and circulating levels of TNF-α
Systemic inflammatory response (CRP)
Time frame: 24 hours
Changes in leukocyte count and circulating levels of CRP
Pericarditis
Time frame: 24 hours
Chest pain suggestive of pericarditis assessed using a numeric pain rating scale (0 to 10)
4 secondary outcomes
Incidence of early arrhythmias
Time frame: 24 hours
Analysis of biomarkers (CD40L)
Time frame: 24 hours
Analysis of biomarkers (Willebrand)
Time frame: 24 hours
Incidence of late atrial arrhythmia recurrence
Time frame: 6 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 17 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Pierre JAÏS, MD study director
University Hospital, Bordeaux
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 and Catheter Ablation, run by University Hospital, Bordeaux 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 3 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 17 Jun 2025. 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?
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?
Acute thromboinflammatory response (time frame: 24 hours). The study lists 5 primary outcomes in all. 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 17 Jun 2025.