Persistant Atrial FibrillationPF-MRI+NCT07499531
The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
A study testing Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation in people with Persistant Atrial Fibrillation and Paroxysmal AF, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance. The goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistant Atrial Fibrillation, Paroxysmal AF
- What is being tested?
- Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18
- Established diagnosis of persistent or paroxysmal atrial fibrillation with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
- AF ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
- Episode of AF documented by ECG within the last 12 months
- Patient able to give written informed consent
- If female of childbearing potential, have a negative serum pregnancy test and using effective contraception
- Be affiliated with a French social security system or entitled
Who cannot join
- Only pulmonary vein isolation is scheduled
- Atrial fibrillation present at ECG during the pre-ablation (V1a) visit
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- Previous ablation in the left atrium
- Previous heart surgery
Show all 12Show fewer
- Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis
- Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR < 30 mL/min, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)
- Patient on AME (state medical aid)
- Pregnant or breast-feeding female
- Patient protected by law (guardianship, tutelage measure, deprived of liberty)
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance.
The goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure.
Read the detailed description
Until recently, pulmonary vein ablation was performed using thermal energy; Pulmonary vein ablation (PVA) is the cornerstone of catheter ablation techniques for the treatment of atrial fibrillation (AF). In paroxysmal atrial fibrillation (PAF), PVI achieves a high rate of sustained freedom from AF recurrence, due to the predominant role of AF triggers, primarily represented by the pulmonary veins (PVs). Until recently, two main ablation energies were used to perform PVI: radiofrequency (RF) and cryoablation, both of which rely on thermal injury to the atrial cardiomyocytes surrounding the pulmonary vein ostia. Thermal lesions are associated with coagulative necrosis, oedema, and macro- and microvascular damage. Over time, thermal ablation lesions are replaced by interstitial fibrosis, a non-contractile and inflexible tissue. It has been demonstrated that extensive ablation lesions in the left atrium (LA) exacerbate atrial cardiomyopathy by impairing the LA's reservoir function, which can lead to stiff left atrium syndrome. Furthermore, thermal ablation lesions have been associated with an increased risk of stroke, particularly in patients with a low fibrosis burden in the LA.
Pulsed-field ablation of atrial fibrillation, including ablation of the posterior wall, is associated with the absence of left atrial fibrosis or fatty metaplasia, as well as the preservation of left atrial mechanics and blood flow.
- Conditions
- Persistant Atrial Fibrillation, Paroxysmal AF
- Being tested
- Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
- Keywords
- Catheter Ablation
- 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 ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolationProcedure or surgery
Persistent or paroxysmal atrial fibrillation treated by pulse-field ablation. Interventions added by the study are cardiac MRI (pre-ablation and 4 months after ablation) with administration of contrast agent (Dotarem®).
| Study group | Role | What they receive |
|---|---|---|
| Atrial ablation including at least pulmonary vein isolation and posterior wall isolation | Experimental | The intervention under investigation is pulse-field ablation (PFA) which is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes. Receives: Procedure: Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between baseline (pre-ablation) and post-ablation (4 months) in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (MRI measurement).
Measured: From baseline to 4 months post ablation
Secondary outcomes (5)
Difference between baseline (pre-ablation) and post-ablation (4 months) in global left atrial strain (%)
Measured: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in regional left atrial strains (%)
Measured: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) LA adipose tissue, measured by CT (cm^2, mm^3, %)
Measured: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) left atrial flow assessed by 4D-flow MRI and quantified by velocity histograms (cm/s); vortices number, characterization (n) and duration (ms) ; LA stasis
Measured: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in left atrial wall thickness (mm)
Measured: From baseline to 4 months post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistant Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Houria Mebarek, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499531
- Acronym
- PF-MRI+
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07499531
- Acronym / sponsor ID
- PF-MRI+
- Conditions
- Persistant Atrial Fibrillation, Paroxysmal AF
- Keywords
- Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Mar 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.
Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance.
The goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure.
Detailed description
Until recently, pulmonary vein ablation was performed using thermal energy; Pulmonary vein ablation (PVA) is the cornerstone of catheter ablation techniques for the treatment of atrial fibrillation (AF). In paroxysmal atrial fibrillation (PAF), PVI achieves a high rate of sustained freedom from AF recurrence, due to the predominant role of AF triggers, primarily represented by the pulmonary veins (PVs). Until recently, two main ablation energies were used to perform PVI: radiofrequency (RF) and cryoablation, both of which rely on thermal injury to the atrial cardiomyocytes surrounding the pulmonary vein ostia. Thermal lesions are associated with coagulative necrosis, oedema, and macro- and microvascular damage. Over time, thermal ablation lesions are replaced by interstitial fibrosis, a non-contractile and inflexible tissue. It has been demonstrated that extensive ablation lesions in the left atrium (LA) exacerbate atrial cardiomyopathy by impairing the LA's reservoir function, which can lead to stiff left atrium syndrome. Furthermore, thermal ablation lesions have been associated with an increased risk of stroke, particularly in patients with a low fibrosis burden in the LA.
Pulsed-field ablation of atrial fibrillation, including ablation of the posterior wall, is associated with the absence of left atrial fibrosis or fatty metaplasia, as well as the preservation of left atrial mechanics and blood flow.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial ablation including at least pulmonary vein isolation and posterior wall isolation | Experimental | Procedure: Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolationThe intervention under investigation is pulse-field ablation (PFA) which is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age ≥ 18
- Established diagnosis of persistent or paroxysmal atrial fibrillation with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
- AF ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
- Episode of AF documented by ECG within the last 12 months
- Patient able to give written informed consent
Key exclusion criteria (12 listed)
- Only pulmonary vein isolation is scheduled
- Atrial fibrillation present at ECG during the pre-ablation (V1a) visit
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- Previous ablation in the left atrium
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 ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolationPersistent or paroxysmal atrial fibrillation treated by pulse-field ablation. Interventions added by the study are cardiac MRI (pre-ablation and 4 months after ablation) with administration of contrast agent (Dotarem®). | Procedure or surgery | Atrial ablation including at least pulmonary vein isolation and posterior wall isolation |
Primary outcome
Difference between baseline (pre-ablation) and post-ablation (4 months) in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (MRI measurement).
Time frame: From baseline to 4 months post ablation
5 secondary outcomes
Difference between baseline (pre-ablation) and post-ablation (4 months) in global left atrial strain (%)
Time frame: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in regional left atrial strains (%)
Time frame: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) LA adipose tissue, measured by CT (cm^2, mm^3, %)
Time frame: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) left atrial flow assessed by 4D-flow MRI and quantified by velocity histograms (cm/s); vortices number, characterization (n) and duration (ms) ; LA stasis
Time frame: From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in left atrial wall thickness (mm)
Time frame: From baseline to 4 months post ablation
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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Persistant Atrial Fibrillation
Active, not recruiting
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Persistant Atrial Fibrillation
Active, not recruiting
Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation
Persistant Atrial Fibrillation
Not yet recruitingPhase 2/3
Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Atrial Fibrillation
Recruiting
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Persistant 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.
Houria Mebarek study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation in people with Persistant Atrial Fibrillation and Paroxysmal AF, run by Assistance Publique - Hôpitaux de Paris.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mikael Laredo, MD, PhD (+33 1 84 82 76 20, mikael.laredo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between baseline (pre-ablation) and post-ablation (4 months) in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (MRI measurement). (time frame: From baseline to 4 months post ablation). 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 30 Mar 2026.