Atrial FibrillationDEFINE-PFANCT07462910
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
A study testing Dynamic fluoroscopy in people with Atrial Fibrillation, run by French Cardiology Society at 9 sites in 3 countries.
Trial summary
Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. 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?
- Dynamic fluoroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 2 Jun 2026to 31 May 2027
- 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
- Men and women aged 18 years or older at the time of signing the consent (age≥ 18).
- Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects).
- Indication for ablation decided as part of routine care, according to the recommendations of learned societies.
- First, ablation procedure (including pulmonary vein isolation) planned with the use of a commercially available Pulsed Field Ablation catheter.
- Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital).
- Free, informed and signed consent by the patient before any data collection
Who cannot join
- Known history of diaphragmatic paralysis (right or bilateral) or pre-existing clinical suspicion.
- History of atrial fibrillation ablation.
- History of neuromuscular disease.
- History of major thoracic surgery or chronic pulmonary pathology that may impair diaphragmatic kinetics.
- Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as:
- Cranio-caudal excursion amplitude ≤35 mm on both hemidiaphragms, Or
Show all 14Show fewer
- An asymmetry in contraction amplitude ≥15% between the two sides.
- Inability to perform a post-procedure follow-up fluoroscopy (logistical limitation, patient refusal, contraindication to irradiation).
- Pregnancy or breastfeeding in progress.
- Concurrent participation in another interventional study that may interfere with the objectives of this research.
- Major impairment in cognitive function or inability to understand the objectives of the study or sign a valid consent.
- Individuals deprived of liberty by judicial or administrative decision.
- Adults subject to a legal protection measure (guardianship, curatorship, or judicial protection/safeguard of justice).
- Individuals unable to provide informed consent.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
France7 sites, 7 recruiting
- Not yet recruiting
CHRU de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Arnaud BISSON, MD
- Not yet recruiting
CHU de Lyon - Hôpital Croix-Rousse
Lyon, 69004
Sami FAREH, MD
- Recruiting
Centre Hospitalier de Pau - Hôpital François Mitterrand
Pau, 64046
Hugues BADER, MD
- Not yet recruiting
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
Romain TIXIER, MD
- Not yet recruiting
Centre Cardiologique du Nord
Saint-Denis, 93200
William ESCANDE, MD
- Not yet recruiting
Institut Cardiovasculaire de Strasbourg - Clinique Rhéna
Strasbourg, 67000
Babé BAKOUBOULA, MD
- Not yet recruiting
Clinique Pasteur
Toulouse, 31300
Serge BOVEDA, MD
Canada1 site, 1 recruiting
- Not yet recruiting
Montreal Heart Institute
Montreal, QC H1T 1C8
Laurent MACLE, MD
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland City Hospital
Auckland, 1023
Nigel LEVER, MD
About this study
Official title: Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Prospective Multicentre Study on the Evaluation of the Incidence of Diaphragmatic Paralysis After Pulsed Field Ablation Procedures to Treat Atrial Fibrillation
Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. Its mechanism of action allows tissue selectivity which in theory limits damage to extracardiac structures. However, several cases of right diaphragmatic paralysis have been reported in the literature after PFA, particularly during applications on the right pulmonary veins, near the right phrenic nerve. The available data are from studies without specific diaphragmatic monitoring. The diagnosis of diaphragmatic paralysis is most often based on chest X-ray, a static examination of limited sensitivity, especially for the detection of incomplete paralysis. To date, no prospective multicentre study has evaluated the incidence of diaphragmatic paralysis after PFA with systematic dynamic imaging, such as fluoroscopy, considered the gold standard for the diagnosis of unilateral paralysis.
Read the detailed description
The current study, DEFINE-PFA, aims to include 250 patients spread over 9 centres (France, New-Zealand and Canada). Each patient will benefit from dynamic fluoroscopy before and after the procedure. A new fluoroscopy will be performed at 3 months in patients with a significant reduction (>15%) in postoperative diaphragmatic amplitude.
The primary endpoint is based on the appearance of post-procedure inter-hemi diaphragmatic asymmetry, rather than a simple decrease in craniocaudal amplitude compared to the reference fluoroscopy. Indeed, the absolute diaphragmatic amplitude is highly dependent on the examination conditions, in particular the degree of cooperation of the patient and the intensity of forced inspiration, making inter-examination comparisons unreliable. Conversely, the simultaneous comparison of the two hemidiaphragms during the same inspiratory cycle makes it possible to attenuate these biases by using the contralateral hemidiaphragm as a stable internal reference. Pre-procedure fluoroscopy is nevertheless systematically performed in order to check the absence of basic asymmetry.
The threshold of 15% inter-hemi diaphragmatic asymmetry was empirically retained, in the absence of a cut-off validated in the literature for dynamic fluoroscopy. In diaphragmatic ultrasound, asymmetry is generally considered significant for differences in amplitude > 20% between the two hemi domes, but these measurements are performed successively, which makes them sensitive to variations between respiratory cycles. Conversely, fluoroscopy allows simultaneous observation of the two hemidiaphragms during the same respiratory cycle, offering a more reliable comparison. This threshold aims to detect significant asymmetry while minimizing false positives related to physiological variability.
- Conditions
- Atrial Fibrillation
- Being tested
- Dynamic fluoroscopy
- Keywords
- Pulsed Field Ablation, Fluoroscopy, Diaphragmatic monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic fluoroscopyProcedure or surgery
Fluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Systematic observation of an additional examination (dynamic fluoroscopy) performed before and after a Pulsed Field Ablation procedure, as part of the standard management of atrial fibrillation. Receives: Procedure: Dynamic fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic paralysis
Post-procedural occurrence of diaphragmatic contraction asymmetry, defined as a ≥15% reduction in the cranio-caudal amplitude of a hemi-diaphragm, relative to the contralateral side, measured by dynamic fluoroscopy during a forced breathing cycle, and absent on pre-procedure fluoroscopy.
Measured: Day1: Before the Pulsed Field Ablation and after the Pulsed Field Ablation (at hospital discharge between 2 and 30 hours after ablation, according to a rigorously standardized protocol in all participating centres)
Secondary outcomes (3)
Rate of complete or partial recovery of diaphragmatic function at 3 months.
For patient with diaphragmatic paralysis observed at inclusion visit, diaphragmatic contraction asymmetry evaluation will be redo after 3 months.
Measured: At 3 months
Evaluation of symptoms associated with diaphragmatic paralysis
Presence / absence of symptoms : dyspnea, discomfort on inspiration, decreased physical capacity, sleep disturbances.
Measured: Day 1, at 3 months
Evaluation of the efficiency of the procedure
Comparison, between patients who experienced diaphragmatic paralysis after ablation and those who did not, of the duration of the procedure (in minutes), the duration of the endoscopy (in minutes), the total number of applications and the type of catheter used.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start2 Jun 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective, unblinded, non-randomised, multicentre study conducted in hospitals specializing in rhythmology
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Circle Safe, IHU Lyric, ADIMEP
- Responsible party
- Sponsor
- Investigators
- Romain TIXIER, MD, Study chair, University Hospital, BordeauxFrédéric FRANCESCHI, MD, Study director, CHU Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462910
- Sponsor's protocol ID
- 2025-07
- Acronym
- DEFINE-PFA
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Jun 2026
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation Prospective Multicentre Study on the Evaluation of the Incidence of Diaphragmatic Paralysis After Pulsed Field Ablation Procedures to Treat Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07462910
- Acronym / sponsor ID
- DEFINE-PFA / 2025-07
- Conditions
- Atrial Fibrillation
- Keywords
- Pulsed Field Ablation, Fluoroscopy, Diaphragmatic monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Circle Safe, IHU Lyric, ADIMEP
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 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.
Pulsed Field Ablation (PFA) represents a recent advance in the treatment of atrial fibrillation (AF), with a safety profile potentially superior to traditional thermal techniques, such as radiofrequency or cryoablation. Its mechanism of action allows tissue selectivity which in theory limits damage to extracardiac structures. However, several cases of right diaphragmatic paralysis have been reported in the literature after PFA, particularly during applications on the right pulmonary veins, near the right phrenic nerve. The available data are from studies without specific diaphragmatic monitoring. The diagnosis of diaphragmatic paralysis is most often based on chest X-ray, a static examination of limited sensitivity, especially for the detection of incomplete paralysis. To date, no prospective multicentre study has evaluated the incidence of diaphragmatic paralysis after PFA with systematic dynamic imaging, such as fluoroscopy, considered the gold standard for the diagnosis of unilateral paralysis.
Detailed description
The current study, DEFINE-PFA, aims to include 250 patients spread over 9 centres (France, New-Zealand and Canada). Each patient will benefit from dynamic fluoroscopy before and after the procedure. A new fluoroscopy will be performed at 3 months in patients with a significant reduction (>15%) in postoperative diaphragmatic amplitude.
The primary endpoint is based on the appearance of post-procedure inter-hemi diaphragmatic asymmetry, rather than a simple decrease in craniocaudal amplitude compared to the reference fluoroscopy. Indeed, the absolute diaphragmatic amplitude is highly dependent on the examination conditions, in particular the degree of cooperation of the patient and the intensity of forced inspiration, making inter-examination comparisons unreliable. Conversely, the simultaneous comparison of the two hemidiaphragms during the same inspiratory cycle makes it possible to attenuate these biases by using the contralateral hemidiaphragm as a stable internal reference. Pre-procedure fluoroscopy is nevertheless systematically performed in order to check the absence of basic asymmetry.
The threshold of 15% inter-hemi diaphragmatic asymmetry was empirically retained, in the absence of a cut-off validated in the literature for dynamic fluoroscopy. In diaphragmatic ultrasound, asymmetry is generally considered significant for differences in amplitude > 20% between the two hemi domes, but these measurements are performed successively, which makes them sensitive to variations between respiratory cycles. Conversely, fluoroscopy allows simultaneous observation of the two hemidiaphragms during the same respiratory cycle, offering a more reliable comparison. This threshold aims to detect significant asymmetry while minimizing false positives related to physiological variability.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, unblinded, non-randomised, multicentre study conducted in hospitals specializing in rhythmology
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Dynamic fluoroscopySystematic observation of an additional examination (dynamic fluoroscopy) performed before and after a Pulsed Field Ablation procedure, as part of the standard management of atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 years or older at the time of signing the consent (age≥ 18).
- Diagnosis of paroxysmal or persistent atrial fibrillation, documented in any type of means: ECG, Holter, invasive monitoring (memories of an implantable device) or not (connected objects).
- Indication for ablation decided as part of routine care, according to the recommendations of learned societies.
- First, ablation procedure (including pulmonary vein isolation) planned with the use of a commercially available Pulsed Field Ablation catheter.
- Possibility of performing a fluoroscopic diaphragmatic evaluation before and after the operation (before discharge from the hospital).
Key exclusion criteria (14 listed)
- Known history of diaphragmatic paralysis (right or bilateral) or pre-existing clinical suspicion.
- History of atrial fibrillation ablation.
- History of neuromuscular disease.
- History of major thoracic surgery or chronic pulmonary pathology that may impair diaphragmatic kinetics.
- Evidence of diaphragmatic paralysis on the pre-procedure fluoroscopy loop, defined as:
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 |
|---|---|---|
| Dynamic fluoroscopyFluoroscopic loop recording or continuous digital scopy of the thoracic window, over at least one complete breathing cycle at maximum amplitude. | Procedure or surgery | Intervention |
Primary outcome
Diaphragmatic paralysis
Time frame: Day1: Before the Pulsed Field Ablation and after the Pulsed Field Ablation (at hospital discharge between 2 and 30 hours after ablation, according to a rigorously standardized protocol in all participating centres)
Post-procedural occurrence of diaphragmatic contraction asymmetry, defined as a ≥15% reduction in the cranio-caudal amplitude of a hemi-diaphragm, relative to the contralateral side, measured by dynamic fluoroscopy during a forced breathing cycle, and absent on pre-procedure fluoroscopy.
3 secondary outcomes
Rate of complete or partial recovery of diaphragmatic function at 3 months.
Time frame: At 3 months
Evaluation of symptoms associated with diaphragmatic paralysis
Time frame: Day 1, at 3 months
Evaluation of the efficiency of the procedure
Time frame: Day1
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 10 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Romain TIXIER, MD study chair
University Hospital, Bordeaux
Frédéric FRANCESCHI, MD study director
CHU Marseille
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic fluoroscopy in people with Atrial Fibrillation, run by French Cardiology Society at 9 sites in 3 countries.
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 14 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 10 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 9 sites in France, Canada, New Zealand. 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 Tessa BERGOT, MSc (+33144907033, tessa.bergot@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic paralysis (time frame: Day1: Before the Pulsed Field Ablation and after the Pulsed Field Ablation (at hospital discharge between 2 and 30 hours after ablation, according to a rigorously standardized protocol in all participating centres)). 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 10 Jun 2026.