Atrial Fibrillation (AF)CT-PFANCT07395089
Computed Tomography of Pulse-Field Ablation
An observational study of Atrial Fibrillation (AF) and Arrhythmia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Arrhythmia
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2026to 30 Jun 2026
- 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: All patients at Hôpital Pitié Salpêtrière meeting the study criteria
Who may be able to join
- Age≥18 years at the time of AF ablation
- AF ablation by pulse-field ablation (BOSTON SCIENTIFIC FARAPULSE) or by radiofrequency (any manufacturer) between 2020 and 2024
- Paroxysmal or non-paroxysmal AF
- Pre-ablation CT data available and of high quality
- Post-ablation CT data available and of high quality
- Post-ablation CT performed 3-months (+- 2 weeks) after AF ablation
Who cannot join
- Low quality CT, non-homogeneous contrast agent perfusion
- Post-ablation CT performed in another center
- Patients in which pre- and post-ablation CTs do not share common phases
- Patients who underwent ethanol infusion in the vein of Marshall
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial Remodeling Associated With Pulse-Field Ablation of Atrial Fibrillation: a Computed Tomography Study
Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. In contrast, pulse field ablation (PFA), a novel non-thermal technology, offers a promising efficacy and safety profile without inducing persistent atrial fibrosis. While RFCA-associated reverse atrial remodeling is well-documented, it remains uncertain whether PFA, operating on a non-thermal paradigm, also promotes this remodeling, which would enhance its physiological relevance in AF treatment. Additionally, RFCA studies show that LA wall thickness at the pulmonary vein (PV) antrum can predict PV reconnection and arrhythmia recurrence, but whether PFA affects LA thinning or enables similar predictions from post-treatment computed tomography (CT) scans is unknown. Moreover, epicardial adipose tissue (EAT), strongly linked to LA abnormalities and AF recurrence, can be quantified via CT, yet the impact of PFA on LA EAT remains unexplored. Finally, PFA's versatility, particularly in isolating the LA posterior wall (LAPW) in non-paroxysmal AF, raises questions about its effect on posterior wall thinning or EAT changes, factors associated with post-ablation recurrence
- Conditions
- Atrial Fibrillation (AF), Arrhythmia
- Keywords
- Ablation, Reverse Atrial Remodeling, Radiofrequency Catheter Ablation, Pulse Field Ablation, Pulmonary Vein Reconnexion, Epicardial Adipose Tissue
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulse-Field Ablation | Not described | |
| Radiofrequency Catheter Ablation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between baseline and post-ablation LA indexed volume (ml/cm^2)
Measured: Post-procedural (3-months)
Secondary outcomes (8)
Difference between baseline and post-ablation mean wall thickness, mm
Measured: Post-procedural (3-months)
Difference between baseline and post-ablation Epicardial adipose tissue , mm^3
Measured: Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage indexed volume, ml/cm^2
Measured: Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage dimensions (long-axis, short-axis, ostium long-axis, ostium short-axis), mm
Measured: Post-procedural (3-months)
Difference between baseline and post-ablation mean LA wall thickness at the LAPW, mm
Measured: Post-procedural (3-months)
Difference between baseline and post-ablation epicardial adipose tissue at the PW, mm^3
Measured: Post-procedural (3-months)
Recurrence of sustained atrial arrhythmia
Measured: Post-procedural (3-months)
Recurrence of sustained atrial arrhythmia
Measured: 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Apr 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Carine Paré, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395089
- Sponsor's protocol ID
- APHP250617
- Acronym
- CT-PFA
- Status last verified
- Sep 2026
- First submitted
- 28 Nov 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Remodeling Associated With Pulse-Field Ablation of Atrial Fibrillation: a Computed Tomography Study
- ClinicalTrials.gov ID
- NCT07395089
- Acronym / sponsor ID
- CT-PFA / APHP250617
- Conditions
- Atrial Fibrillation (AF), Arrhythmia
- Keywords
- Ablation, Reverse Atrial Remodeling, Radiofrequency Catheter Ablation, Pulse Field Ablation, Pulmonary Vein Reconnexion, Epicardial Adipose Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Feb 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.
Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) reduces left atrial (LA) volume post-ablation, a phenomenon termed reverse atrial remodeling, indicative of successful reversal of atrial cardiomyopathy progression. In contrast, pulse field ablation (PFA), a novel non-thermal technology, offers a promising efficacy and safety profile without inducing persistent atrial fibrosis. While RFCA-associated reverse atrial remodeling is well-documented, it remains uncertain whether PFA, operating on a non-thermal paradigm, also promotes this remodeling, which would enhance its physiological relevance in AF treatment. Additionally, RFCA studies show that LA wall thickness at the pulmonary vein (PV) antrum can predict PV reconnection and arrhythmia recurrence, but whether PFA affects LA thinning or enables similar predictions from post-treatment computed tomography (CT) scans is unknown. Moreover, epicardial adipose tissue (EAT), strongly linked to LA abnormalities and AF recurrence, can be quantified via CT, yet the impact of PFA on LA EAT remains unexplored. Finally, PFA's versatility, particularly in isolating the LA posterior wall (LAPW) in non-paroxysmal AF, raises questions about its effect on posterior wall thinning or EAT changes, factors associated with post-ablation recurrence
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulse-Field Ablation | – | – |
| Radiofrequency Catheter Ablation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients at Hôpital Pitié Salpêtrière meeting the study criteria
Key inclusion criteria (6 listed)
- Age≥18 years at the time of AF ablation
- AF ablation by pulse-field ablation (BOSTON SCIENTIFIC FARAPULSE) or by radiofrequency (any manufacturer) between 2020 and 2024
- Paroxysmal or non-paroxysmal AF
- Pre-ablation CT data available and of high quality
- Post-ablation CT data available and of high quality
Key exclusion criteria (4 listed)
- Low quality CT, non-homogeneous contrast agent perfusion
- Post-ablation CT performed in another center
- Patients in which pre- and post-ablation CTs do not share common phases
- Patients who underwent ethanol infusion in the vein of Marshall
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
Difference between baseline and post-ablation LA indexed volume (ml/cm^2)
Time frame: Post-procedural (3-months)
8 secondary outcomes
Difference between baseline and post-ablation mean wall thickness, mm
Time frame: Post-procedural (3-months)
Difference between baseline and post-ablation Epicardial adipose tissue , mm^3
Time frame: Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage indexed volume, ml/cm^2
Time frame: Post-procedural (3-months)
Difference between baseline and post-ablation left atrial appendage dimensions (long-axis, short-axis, ostium long-axis, ostium short-axis), mm
Time frame: Post-procedural (3-months)
Difference between baseline and post-ablation mean LA wall thickness at the LAPW, mm
Time frame: Post-procedural (3-months)
Difference between baseline and post-ablation epicardial adipose tissue at the PW, mm^3
Time frame: Post-procedural (3-months)
Recurrence of sustained atrial arrhythmia
Time frame: Post-procedural (3-months)
Recurrence of sustained atrial arrhythmia
Time frame: 12 months after procedure
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 8 Sep 2026.
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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.
Carine Paré 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?
An observational study of Atrial Fibrillation (AF) and Arrhythmia, 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 4 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 8 Sep 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?
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?
Difference between baseline and post-ablation LA indexed volume (ml/cm^2) (time frame: Post-procedural (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 8 Sep 2026.