Atrial Fibrillation (AF)Define-PFANCT07127900
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
An observational study of Atrial Fibrillation (AF) and Phrenic Nerve-related Diaphragmatic Impairment, run by Laurent Macle.
Trial summary
This study aims to better understand the potential side effects of a heart treatment called PFA (Pulsed Field Ablation), used to treat an arrhythmia known as atrial fibrillation. This technique has already been in clinical use for several years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Phrenic Nerve-related Diaphragmatic Impairment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Apr 2027
- 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: The study plans to include 250 consecutive patients undergoing atrial fibrillation ablation by PFA, regardless of the "one-shot" system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.
Who may be able to join
- Diagnosis of paroxysmal or persistent atrial fibrillation (AF), documented by any method: ECG, Holter, invasive monitoring (implantable device memory), or non-invasive monitoring (connected devices).
- Ablation indication decided as part of routine care, according to society guidelines.
- First ablation procedure (including pulmonary vein isolation) planned using a commercially available PFA catheter.
- Ability to perform diaphragmatic fluoroscopic evaluation before and after the procedure (before hospital discharge).
Who cannot join
- Patients presenting with one or more of the following conditions will be excluded from the study:
- Known history of diaphragmatic paralysis (right-sided or bilateral) or preexisting clinical suspicion.
- History of atrial fibrillation ablation.
- History of neuromuscular disease.
- History of major thoracic surgery or chronic pulmonary pathology likely to impair diaphragmatic motion.
- Diaphragmatic paralysis diagnosed during the pre-procedure fluoroscopic assessment.
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- Inability to perform post-procedure fluoroscopic control (due to logistical limitations, patient refusal, or contraindication to radiation exposure).
- Current pregnancy or breastfeeding.
- Concurrent participation in another interventional study that may interfere with the objectives of the present research.
- Significant cognitive impairment or inability to understand the study objectives or provide valid consent.
About this study
Official title: Define-PFA: Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
This study aims to better understand the potential side effects of a heart treatment called PFA (Pulsed Field Ablation), used to treat an arrhythmia known as atrial fibrillation. This technique has already been in clinical use for several years.
The goal of the study is to detect a possible adverse effect of this procedure: injury to the phrenic nerve, which could result in paralysis of one side of the diaphragm. The diaphragm is an important muscle for breathing and can occasionally be affected during certain cardiac ablation procedures.
Read more
To assess this, patients will undergo a dynamic chest X-ray (fluoroscopy) before and after the procedure. If diaphragm movement appears reduced afterward, a follow-up exam will be performed at 3 months to monitor the evolution. Patients presenting with a fluoroscopic abnormality at Month 3 will undergo a follow-up at Month 6. If the abnormality persists at M6, follow-up will be extended to Month 12.
The study does not involve any experimental treatment or changes to standard medical care, and there are no additional risks associated with the planned exams. It is entirely observational. All data will be used anonymously to help improve the safety of current techniques.
Read the detailed description
Study Type This is a prospective, observational, multicenter study conducted in four electrophysiology centers. The study does not involve any experimental intervention or modification of standard care. It is based on the systematic observation of a complementary imaging exam (dynamic fluoroscopy) performed before and after a PFA procedure, as part of the routine management of atrial fibrillation.
Participation Duration
The maximum duration of participation for each patient is twelve (12) months. Follow-up includes:
an inclusion visit with pre-procedure fluoroscopy,
a post-procedure fluoroscopy performed before hospital discharge (on the day of the procedure or the following day, depending on local practices),
a 3-6 and 12 month visit with fluoroscopy, only if an abnormality was detected in the post-procedure assessment.
General Methodology The study aims to include 250 consecutive patients undergoing PFA for atrial fibrillation, regardless of the single-shot system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.
Dynamic fluoroscopy will be performed before the catheter ablation using a PFA system, and repeated afterward before the patient's discharge-on the same day or the following day, depending on the center's practice. The images will be stored and analyzed to assess diaphragmatic excursion (in millimeters). Exams will be considered of sufficient quality if the excursion of at least one hemidiaphragm is ≥35 mm, and optimal if ≥40 mm. Diaphragmatic impairment will be defined as an asymmetry ≥15% in cranio-caudal excursion between hemidiaphragms after the procedure. Patients with diaphragmatic impairment will be invited for a follow-up fluoroscopy at three months.
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of diaphragmatic abnormality
asymmetry ≥ 15%, paradoxical excursion
Measured: Hospital discharge
Secondary outcomes (3)
Respiratory symptoms associated with diaphragmatic paralysis
dyspnea, inspiratory discomfort, reduced physical capacity
Measured: Hospital discharge: up to 48hrs post-procedure
Correlation between technical characteristics of the ablation and the occurrence of diaphragmatic paralysis.
in particular, the type of catheter used
Measured: Hospital discharge: up to 48hrs post-procedure
Final status of the recovery of diaphragmatic abnormalities
complete recovery / partial recovery / no recovery of diaphragmatic abnormalities
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Why it stopped: For administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurent Macle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurent Macle, Montreal Heart Institute
- Investigators
- Laurent Macle, MD, Principal investigator, Montreal Heart Institute - Montréal, QCFrederic Franceschi, MD. Pr., Principal investigator, Auckland City Hospital (ACH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127900
- Sponsor's protocol ID
- ICM-2026-3595
- Acronym
- Define-PFA
- Status last verified
- Sep 2025
- First submitted
- 4 Aug 2025
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Define-PFA: Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
- ClinicalTrials.gov ID
- NCT07127900
- Acronym / sponsor ID
- Define-PFA / ICM-2026-3595
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: For administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laurent MacleUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Aug 2025 (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.
This study aims to better understand the potential side effects of a heart treatment called PFA (Pulsed Field Ablation), used to treat an arrhythmia known as atrial fibrillation. This technique has already been in clinical use for several years.
The goal of the study is to detect a possible adverse effect of this procedure: injury to the phrenic nerve, which could result in paralysis of one side of the diaphragm. The diaphragm is an important muscle for breathing and can occasionally be affected during certain cardiac ablation procedures.
To assess this, patients will undergo a dynamic chest X-ray (fluoroscopy) before and after the procedure. If diaphragm movement appears reduced afterward, a follow-up exam will be performed at 3 months to monitor the evolution. Patients presenting with a fluoroscopic abnormality at Month 3 will undergo a follow-up at Month 6. If the abnormality persists at M6, follow-up will be extended to Month 12.
The study does not involve any experimental treatment or changes to standard medical care, and there are no additional risks associated with the planned exams. It is entirely observational. All data will be used anonymously to help improve the safety of current techniques.
Detailed description
Study Type This is a prospective, observational, multicenter study conducted in four electrophysiology centers. The study does not involve any experimental intervention or modification of standard care. It is based on the systematic observation of a complementary imaging exam (dynamic fluoroscopy) performed before and after a PFA procedure, as part of the routine management of atrial fibrillation.
Participation Duration
The maximum duration of participation for each patient is twelve (12) months. Follow-up includes:
an inclusion visit with pre-procedure fluoroscopy,
a post-procedure fluoroscopy performed before hospital discharge (on the day of the procedure or the following day, depending on local practices),
a 3-6 and 12 month visit with fluoroscopy, only if an abnormality was detected in the post-procedure assessment.
General Methodology The study aims to include 250 consecutive patients undergoing PFA for atrial fibrillation, regardless of the single-shot system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.
Dynamic fluoroscopy will be performed before the catheter ablation using a PFA system, and repeated afterward before the patient's discharge-on the same day or the following day, depending on the center's practice. The images will be stored and analyzed to assess diaphragmatic excursion (in millimeters). Exams will be considered of sufficient quality if the excursion of at least one hemidiaphragm is ≥35 mm, and optimal if ≥40 mm. Diaphragmatic impairment will be defined as an asymmetry ≥15% in cranio-caudal excursion between hemidiaphragms after the procedure. Patients with diaphragmatic impairment will be invited for a follow-up fluoroscopy at three months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study plans to include 250 consecutive patients undergoing atrial fibrillation ablation by PFA, regardless of the "one-shot" system used (FARAPULSE™, PULSE SELECT™, VARIPULSE™, or VOLT™), at the discretion of each operator.
Key inclusion criteria (4 listed)
- Diagnosis of paroxysmal or persistent atrial fibrillation (AF), documented by any method: ECG, Holter, invasive monitoring (implantable device memory), or non-invasive monitoring (connected devices).
- Ablation indication decided as part of routine care, according to society guidelines.
- First ablation procedure (including pulmonary vein isolation) planned using a commercially available PFA catheter.
- Ability to perform diaphragmatic fluoroscopic evaluation before and after the procedure (before hospital discharge).
Key exclusion criteria (10 listed)
- Patients presenting with one or more of the following conditions will be excluded from the study:
- Known history of diaphragmatic paralysis (right-sided or bilateral) or preexisting clinical suspicion.
- History of atrial fibrillation ablation.
- History of neuromuscular disease.
- History of major thoracic surgery or chronic pulmonary pathology likely to impair diaphragmatic motion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of diaphragmatic abnormality
Time frame: Hospital discharge
asymmetry ≥ 15%, paradoxical excursion
3 secondary outcomes
Respiratory symptoms associated with diaphragmatic paralysis
Time frame: Hospital discharge: up to 48hrs post-procedure
Correlation between technical characteristics of the ablation and the occurrence of diaphragmatic paralysis.
Time frame: Hospital discharge: up to 48hrs post-procedure
Final status of the recovery of diaphragmatic abnormalities
Time frame: 12 months post-procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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. This study is not recruiting at the moment.
Laurent Macle, MD principal investigator
Montreal Heart Institute - Montréal, QC
Frederic Franceschi, MD. Pr. principal investigator
Auckland City Hospital (ACH)
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Phrenic Nerve-related Diaphragmatic Impairment, run by Laurent Macle.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 1 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Presence or absence of diaphragmatic abnormality (time frame: Hospital discharge). 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 1 Oct 2025.