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New catheter trial aims to stop AFib recurrence

NCT ID NCT06747091

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This trial compares three different catheter ablation strategies for people with persistent atrial fibrillation (AFib), a heart rhythm problem. Sixty adults aged 18-80 will be randomly assigned to one of three approaches using a special catheter that can switch between two energy types. The goal is to see which strategy best prevents AFib from coming back over 12 months.

What this could mean

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

Active substance
catheter ablation using a lattice-tip catheter that can switch between radiofrequency and pulsed field energy
What this could lead to
If successful, this could identify the best ablation strategy to reduce recurrence of atrial fibrillation, improving long-term heart rhythm control.
What could go wrong
This is a small, early-stage trial (60 participants) comparing different procedures, so results may not apply broadly. Ablation carries risks like bleeding, infection, or heart damage.

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 60 people

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

Started

Mar 2025

Expected to finish

Mar 2027

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 to 80 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 PerAF documented by (1a) a physician's note indicating symptoms consistent with AF sustained longer than 7 days but less than 12 months; AND electrocardiographic evidence 2\. . Suitable candidate for catheter ablation. 3\. . Adults aged 18 - 80 years. 4\. . Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or other reversible or non-cardiac cause. 2. Previous left atrial ablation or surgical procedure (including septal closure or left atrial appendage closure). 3. Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). 4. Any carotid stenting or endarterectomy. 5. Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within the 90 days prior to the initial procedure. 6. Coronary artery bypass graft (CABG) procedure within the 6 months prior to the initial procedure. 7. Awaiting cardiac transplantation or other cardiac surgery within the 12 months following the initial ablation procedure. 8. Documented thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the initial ablation procedure. 9. Documented left atrial thrombus on imaging. 10. History of blood clotting or bleeding abnormalities. 11. Any condition contraindicating chronic anticoagulation. 12. Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure. 13. Body mass index \>40 kg/m2. 14. Left atrial diameter \>55 mm (anterioposterior). 15. Diagnosed atrial myxoma. 16. Uncontrolled heart failure or NYHA Class III or IV heart failure. 17. Rheumatic heart disease. 18. Hypertrophic cardiomyopathy. 19. Unstable angina. 20. Moderate to severe mitral valve stenosis. 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 22. Primary pulmonary hypertension. 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 24. Renal failure requiring dialysis. 25. History of severe Gastroesophageal Reflux Disease (GERD) requiring surgical and/or mechanical intervention. 26. Acute illness, active systemic infection, or sepsis. 27. Contraindication to both computed tomography and magnetic resonance angiography. 28. 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 study results. 29. Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor. 30. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation. 31. Known drug or alcohol dependency. 32. Life expectancy less than 12 months.

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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

    3 sites. 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

  • Kristie Coleman

    RECRUITING

    New York, New York, 10075, United States

  • Long Island Jewish Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

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