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New catheter aims to tame irregular heartbeat

NCT ID NCT05144503

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests a new device called the SpherePVI catheter, which uses heat to isolate the veins that trigger atrial fibrillation. About 100 adults with symptomatic AF who haven't responded to medication will be enrolled. The main goals are to see if the procedure is safe and can successfully stop the abnormal electrical signals.

What this could mean

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

Active substance
SpherePVI™ Catheter with the Affera Mapping and Ablation System
What this could lead to
If successful, this could offer a safer and more effective way to control atrial fibrillation, reducing symptoms and improving quality of life.
What could go wrong
This is a small, early-stage study with no control group. The device may cause serious side effects like stroke or heart damage, and long-term benefits are not yet proven.

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 100 people

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

Started

Jul 2021

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 75 years

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: 1. Symptomatic paroxysmal or persistent atrial fibrillation documented by: * A physician's note indicating recurrent AF * At least two electrocardiographically documented AF episodes within 12 months prior to enrollment 2. Failure or intolerance of at least one Class I-IV anti-arrhythmic drug. 3. Suitable candidate for catheter ablation. 4. Age ≥ 18 and \< 75 years. 5. Able and willing to give informed consent. 6. Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements Exclusion Criteria: Subjects will not be eligible for the study if any of the following criteria are met: 1. Continuous AF lasting more than 12 months (long-standing persistent AF). 2. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause. 3. Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure). 4. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). 5. Any carotid stenting or endarterectomy. 6. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure. 7. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure. 8. Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure. 9. Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function). 10. Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days). 11. Documented left atrial thrombus on imaging. 12. History of blood clotting or bleeding abnormalities. 13. Any condition contraindicating chronic anticoagulation. 14. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. 15. Body mass index \>40 kg/m2. 16. Left atrial diameter (anteroposterior) \>50 mm for paroxysmal AF and \>55mm for persistent AF. 17. Diagnosed atrial myxoma. 18. Left ventricular ejection fraction (EF) \< 40%. 19. Uncontrolled heart failure or NYHA Class III or IV heart failure. 20. Rheumatic heart disease. 21. Hypertrophic cardiomyopathy. 22. Unstable angina. 23. Moderate to severe mitral valve stenosis. 24. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 25. Primary pulmonary hypertension. 26. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 27. Renal failure requiring dialysis. 28. Acute illness, active systemic infection, or sepsis. 29. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. 30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence. 31. Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor. 32. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. 33. Known drug or alcohol dependency. 34. Life expectancy less than 12 months. 35. Vulnerable subject.

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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.

  1. The places running it

    1 site. 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

  • Vilnius University Hospital

    RECRUITING

    Vilnius, Lithuania

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