Duel of ablation catheters: which wins for persistent AF?
NCT ID NCT07815171
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
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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
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
10 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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1st Department of Cardiology, National and Kapodistrian University of Athens, Hippokrateion Hospital
Athens, Greece
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7th Cardiology Department, Hygeia Hospital
Athens, Greece
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8th Cardiology Department, Hygeia Hospital
Athens, Greece
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Cardiology Department, 12th of October University Hospital
Madrid, Spain
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Department of Cardiology, Inselspital, Bern University Hospital, University of Bern
Bern, Switzerland
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Department of Cardiology, Jean Monnet University
Saint-Etienne, France
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Department of Cardiology, Thorax Center, Cardiovascular Institute, Erasmus Medical Center
Rotterdam, Netherlands
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Heart Rhythm Center, IASO Hospital
Athens, Greece
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Institut de Cardiologie, Hôpital Universitaire Pitié-Salpêtriere, AP-HP, Sorbonne Université
Paris, France
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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.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Can a new drug stop long atrial fibrillation episodes?
- Which ablation method wins for tough atrial fibrillation cases?
- Can a diabetes drug keep the heart in rhythm?
- Can a cholesterol drug keep atrial fibrillation at bay after ablation?