Persistent Atrial FibrillationPersAF ICMNCT06985901
Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
A study testing Persistent atrial fibrillation ablation using Pulsed-field ablation in people with Persistent Atrial Fibrillation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a validated therapeutic option for persistent AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Persistent atrial fibrillation ablation using Pulsed-field ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2026to 13 Apr 2030
- 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
- Symptomatic persistent AF (continuous episode sustained beyond 7 days)
- Refractory, intolerant or unwilling to take ADT
- Signed informed consent
- Affiliation to medical social coverage.
- Non inclusion Criteria:
- Persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years;
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- Left ventricular ejection fraction ≤ 15% ;
- Stage IV of the New York Heart Association classification;
- Previous atrial ablation outside the cavotricuspid isthmus;
- Wearer of an implantable electronic cardiac prosthesis (pacemaker or defibrillator; MCI)
- Hypertrophic heart disease other than hypertensive hypertrophic heart disease;
- Severe valvular heart disease, including the presence of a mechanical mitral valve or any mitral surgery;
- Congenital heart disease, including atrial septal defect, patent foramen ovale treated by percutaneous closure with atrial septal prosthesis;
- Presence of cardiac thrombus;
- Myocardial infarction or percutaneous coronary angioplasty within the last 6 months;
- Cardiac surgery within the last 6 months;
- Systemic thromboembolic event less than 6 months ago;
- Pulmonary embolism less than 6 months ago or pulmonary hypertension requiring specific treatment;
- Inability to read independently
- Vulnerable patient: minor, patient under curatorship or guardianship
Who cannot join
None listed.
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
CHU de Nice
Nice
Sok-Sithikun Dr BUN, 04 92 03 77 33, bun.s@chu-nice.fr
About this study
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a validated therapeutic option for persistent AF. Recently, Pulsed-field ablation (PFA) - a new non-thermal energy - has been used to treat paroxysmal and persistent AF with a high success rate in observational studies. This new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. Before confirming a superiority of PFA over existing thermal energies, prospective studies concerning an exclusive population of persistent AF patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor [ICM]). PFA efficacy using ICM has never been evaluated. Before considering PFA in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent AF population-only. This pilot cohort study will provide solid data of PFA efficacy (using continuous monitoring of recurrences) for future randomized studies.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Persistent atrial fibrillation ablation using Pulsed-field 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.
Persistent atrial fibrillation ablation using Pulsed-field ablationProcedure or surgery
Pulmonary vein isolation with pulsed-field ablation coupled with 3D electroanatomic mapping. Follow-up with insertable cardiac monitor.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic persistent atrial fibrillation | Experimental | Not described Receives: Procedure: Persistent atrial fibrillation ablation using Pulsed-field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF.
Efficacy will be assessed by the absence of AF/AT (episodes > 2min) recurrences during a 12-month follow-up period (clinical success) based upon continuous monitoring (ICM). Recurrence will be defined as any AF/AT episode > 2 min (detected by ICM) after the 2-month blanking period.
Measured: 12 months
Secondary outcomes (2)
Quantify the total atrial arrhythmias burden (AF/AT) over a 12-months period
Efficacy will be assessed by total AF/AT burden (recurrence as defined in the main criterion of evaluation), recorded by the ICM, and defined as the total period of time spent in AF/AT over the 12-month follow-up period (after the 2-month blanking period; assessment period of 10 months)
Measured: 12 months
Assess patient distribution according to residual arrhythmias burden after one year
Residual AF/AT burden will be categorized into 4 groups: 0-0,1%; >0,1%-1%; >1-10%; >10% of the follow-up period. After calculation of the total AF/AT burden of each patient at M12, he will be classified into one of the above categories.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start13 Apr 2026
- Primary completion13 Apr 2028 (estimated)
- Study completion13 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985901
- Sponsor's protocol ID
- 23-API-03
- Acronym
- PersAF ICM
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 11 Jun 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
- ClinicalTrials.gov ID
- NCT06985901
- Acronym / sponsor ID
- PersAF ICM / 23-API-03
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 13 Apr 2028 (estimated)
- Study completion
- 13 Apr 2030 (estimated)
- First posted
- 22 May 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.
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a validated therapeutic option for persistent AF. Recently, Pulsed-field ablation (PFA) - a new non-thermal energy - has been used to treat paroxysmal and persistent AF with a high success rate in observational studies. This new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. Before confirming a superiority of PFA over existing thermal energies, prospective studies concerning an exclusive population of persistent AF patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor [ICM]). PFA efficacy using ICM has never been evaluated. Before considering PFA in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent AF population-only. This pilot cohort study will provide solid data of PFA efficacy (using continuous monitoring of recurrences) for future randomized studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic persistent atrial fibrillation | Experimental | Procedure: Persistent atrial fibrillation ablation using Pulsed-field ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Symptomatic persistent AF (continuous episode sustained beyond 7 days)
- Refractory, intolerant or unwilling to take ADT
- Signed informed consent
- Affiliation to medical social coverage.
- Persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Persistent atrial fibrillation ablation using Pulsed-field ablationPulmonary vein isolation with pulsed-field ablation coupled with 3D electroanatomic mapping. Follow-up with insertable cardiac monitor. | Procedure or surgery | Symptomatic persistent atrial fibrillation |
Primary outcome
To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF.
Time frame: 12 months
Efficacy will be assessed by the absence of AF/AT (episodes > 2min) recurrences during a 12-month follow-up period (clinical success) based upon continuous monitoring (ICM). Recurrence will be defined as any AF/AT episode > 2 min (detected by ICM) after the 2-month blanking period.
2 secondary outcomes
Quantify the total atrial arrhythmias burden (AF/AT) over a 12-months period
Time frame: 12 months
Assess patient distribution according to residual arrhythmias burden after one year
Time frame: 12 months
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 11 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persistent atrial fibrillation ablation using Pulsed-field ablation in people with Persistent Atrial Fibrillation, run by Centre Hospitalier Universitaire de Nice 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 20 inclusion and 0 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 11 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 Sok-Sithikun BUN, MD, PhD (04 92 03 77 33 ext. +33, bun.s@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF. (time frame: 12 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 11 Jun 2026.