Atrial Fibrillation ParoxysmalPF-MRINCT06557876
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
A study testing Pulmonary vein isolation by pulse field ablation and Pulmonary vein isolation by cryoablation in people with Atrial Fibrillation Paroxysmal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. 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?
- Pulmonary vein isolation by pulse field ablation and Pulmonary vein isolation by cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2024to 1 Oct 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 paroxysmal fibrillation, with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
- 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
- Non-paroxysmal atrial fibrillation
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- Previous ablation in the left atrium
- Previous heart surgery
- 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
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- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Dr Mikael Laredo
Paris, France, 75013
LAREDO, +33184827620, mikael.laredo@aphp.fr
About this study
Official title: The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation
The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:
- Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?
Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.
Researchers will compare 2 arms:
- Pulse-Field Ablation
- Cryoablation
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- Pulmonary vein isolation by pulse field ablation, Pulmonary vein isolation by cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation by pulse field ablationProcedure or surgery
Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.
Pulmonary vein isolation by cryoablationProcedure or surgery
Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation by pulse field ablation | Active comparator | Not described Receives: Procedure: Pulmonary vein isolation by pulse field ablation |
| Pulmonary vein isolation by cryoablation | Active comparator | Not described Receives: Procedure: Pulmonary vein isolation by cryoablation |
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 in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (related to primary objective) (MRI measurement)
Measured: 3 months
Secondary outcomes (15)
Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation LA adipose tissue, measured by CT (cm2, mm3, %) (related to secondary objective 1 and 2) (CT measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement)
Measured: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement)
Measured: 3 months
Heart rate measured the day after ablation and 3 months after (related to secondary objective 4)
Measured: 3 months
SF-36 (Short-Form-36) Physical Health Composite questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result.
Measured: 0 day
SF-36 (Short-Form-36) Physical Health Composite questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result.
Measured: 15 days
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result.
Measured: 0 day
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result.
Measured: 15 days
Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4)
Measured: 1 day
Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start9 Oct 2024
- Primary completion9 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Interventional, single center, prospective, comparative, randomized (ratio of 1:1), open-label study. * With 2 compared groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine CAMUS, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557876
- Sponsor's protocol ID
- APHP230296
- Acronym
- PF-MRI
- Status last verified
- May 2026
- First submitted
- 14 Aug 2024
- Last updated
- 2 Jun 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06557876
- Acronym / sponsor ID
- PF-MRI / APHP230296
- Conditions
- Atrial Fibrillation Paroxysmal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 9 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Aug 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.
The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:
- Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?
Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.
Researchers will compare 2 arms:
- Pulse-Field Ablation
- Cryoablation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Interventional, single center, prospective, comparative, randomized (ratio of 1:1), open-label study. * With 2 compared groups
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation by pulse field ablation | Active comparator | Procedure: Pulmonary vein isolation by pulse field ablation |
| Pulmonary vein isolation by cryoablation | Active comparator | Procedure: Pulmonary vein isolation by cryoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age ≥ 18
- Established diagnosis of paroxysmal fibrillation, with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
- 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
Key exclusion criteria (11 listed)
- Non-paroxysmal atrial fibrillation
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- Previous ablation in the left atrium
- Previous heart surgery
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 |
|---|---|---|
| Pulmonary vein isolation by pulse field ablationPulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes. | Procedure or surgery | Pulmonary vein isolation by pulse field ablation |
| Pulmonary vein isolation by cryoablationCryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device. | Procedure or surgery | Pulmonary vein isolation by cryoablation |
Primary outcome
Difference between baseline (pre-ablation) and post-ablation in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (related to primary objective) (MRI measurement)
Time frame: 3 months
15 secondary outcomes
Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation LA adipose tissue, measured by CT (cm2, mm3, %) (related to secondary objective 1 and 2) (CT measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement)
Time frame: 3 months
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement)
Time frame: 3 months
Heart rate measured the day after ablation and 3 months after (related to secondary objective 4)
Time frame: 3 months
SF-36 (Short-Form-36) Physical Health Composite questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result.
Time frame: 0 day
SF-36 (Short-Form-36) Physical Health Composite questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result.
Time frame: 15 days
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result.
Time frame: 0 day
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result.
Time frame: 15 days
Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4)
Time frame: 1 day
Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4)
Time frame: 15 days
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 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marine CAMUS study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation by pulse field ablation and Pulmonary vein isolation by cryoablation in people with Atrial Fibrillation Paroxysmal, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 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?
Contact Mikael Laredo, MD, PhD (+33184827620, 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 in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (related to primary objective) (MRI measurement) (time frame: 3 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 2 Jun 2026.