Duel of ablation catheters: which wins for persistent AF?

NCT ID NCT07815171

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

Researchers compare two pulsed-field ablation catheters, the Sphere-9 lattice-tip and the FARAPULSE pentaspline, in people with symptomatic persistent atrial fibrillation. All participants undergo pulmonary vein isolation, the only allowed ablation lesion set, and receive an implanted heart rhythm monitor for 12 months. The trial checks whether the Sphere-9 catheter is non-inferior to the FARAPULSE catheter for acute ablation success and freedom from treatment failure, and also compares safety, arrhythmia burden, quality of life, and procedural efficiency.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pulsed-field ablation using the Sphere-9 lattice-tip catheter or the FARAPULSE pentaspline catheter
What this could lead to
If one catheter proves non-inferior, it could offer another option for pulmonary vein isolation in persistent atrial fibrillation.
What could go wrong
The trial may not show equivalence, and ablation carries risks such as stroke, bleeding, or damage to surrounding structures. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Symptomatic AF (EHRA symptom class ≥ II) * Documented persistent AF (continuous AF for \> 7 days and \< 365 days), confirmed within 180 days of enrollment by either a 24-hour Holter recording showing continuous AF, or two ECGs from any regulatory-cleared rhythm monitoring device, taken at least 7 days apart, showing continuous AF * Patients considered eligible for catheter ablation (either refractory/intolerant to ≥1 Class I/III AAD or presenting for first-line ablation per clinical discretion) * Willing and capable of undergoing insertable loop recorder (ILR) implantation at the index procedure and maintaining the conditions required for automatic remote transmission throughout the 12-month study period * Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: Anatomical and procedural exclusions * Previous catheter or surgical ablation, except right-sided atrial ablation for supraventricular tachycardia or cavotricuspid isthmus ablation for atrial flutter * Severe left atrial enlargement: left atrial anteroposterior diameter ≥55 mm or LAVI \>50 mL/m2 * Left atrial or left atrial appendage (LA/LAA) thrombus * Prior pulmonary vein intervention, pulmonary vein stenting, or known severe pulmonary vein stenosis * Presence of an interatrial baffle, ASD/PFO closure device, or surgical patch that, in the investigator's judgment, precludes safe transseptal access Cardiovascular exclusions * New York Heart Association (NYHA) functional class III or IV * Recent acute coronary syndrome, coronary revascularization, cardiac surgery, stroke, or transient ischemic attack within the preceding 90 days * Severe valvular heart disease or prosthetic heart valve/annuloplasty ring * History of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). * Atrial fibrillation secondary to reversible non-cardiac causes. Other exclusions * Presence of an insertable cardiac device (pacemaker, ICD, CRT, or pre-existing non-study ILR) * Contraindication or intolerance to therapeutic systemic anticoagulation * Documented baseline hemi-diaphragmatic paresis or paralysis * Inability, unwillingness, or anatomical contraindication (e.g., implant-site skin or soft-tissue pathology, prior radiation, or chest-wall deformity) to undergo ILR implantation * Severe renal impairment: eGFR\<30 mL/min/1.73 m2 or current/prior renal replacement therapy * Pregnancy or planned pregnancy during the 12-month trial window * Inability or unwillingness to provide informed consent or complete 12 months of trial follow-up

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Persistent atrial fibrillation are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 1st Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital

    Athens, Greece

  • 7th Cardiology Department, Hygeia Hospital

    Athens, Greece

  • 8th Cardiology Department, Hygeia Hospital

    Athens, Greece

  • Cardiology Department, 12th of October University Hospital

    Madrid, Spain

  • Department of Cardiology, Inselspital, Bern University Hospital, University of Bern

    Bern, Switzerland

  • Department of Cardiology, Jean Monnet University

    Saint-Etienne, France

  • Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center

    Rotterdam, Netherlands

  • Heart Rhythm Center, IASO Hospital

    Athens, Greece

  • Institut de Cardiologie, Hôpital Universitaire Pitié-Salpêtriere, AP-HP, Sorbonne Université

    Paris, France

  • Servicio de Cardiología, Hospital Universitari, Politecnic La Fe, Valencia, Spain

    Valencia, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.