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New heart catheter shows promise for stopping AFib episodes

NCT ID NCT06272981

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special catheter and generator system to treat people with paroxysmal atrial fibrillation (AFib), a condition where the heart beats irregularly. The goal was to safely isolate the veins that trigger AFib and restore normal rhythm. 135 participants were treated, and the study measured safety and how well the procedure prevented AFib episodes for up to a year.

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

135 people

The number who actually took part.

Started

Feb 2024

Finished

Oct 2025

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 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:: * Diagnosed with Symptomatic PAF (Physician's note indicating recurrent self-terminating AF). At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or other electrocardiographical devices accepted by investigators * Failed at least one (1) Class I or Class III Antiarrhythmic Drug (AAD) as evidenced by recurrent symptomatic AF or has intolerable side effects or is contraindicated to the Class I or Class III AAD * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Willing and capable of providing consent Exclusion Criteria: * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., untreated documented obstructive sleep apnea and acute alcohol toxicity) * Previous LA ablation or surgery * Patients known to require ablation outside the PV region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White) * Previously diagnosed with persistent AF (\> 7 days in duration) * Severe dilatation of the LA (documented LAD \>50mm antero-posterior diameter on imaging within 6 months prior to enrollment * Documented left atrium (LA) thrombus within 48 hours prior to the index procedure by Transesophageal Echocardiography (TEE), or by Intracardiac Echocardiography (ICE) prior to transeptal puncture during procedure * Documented severely compromised LVEF (LVEF \<40%) by imaging within 6 months prior to enrollment * Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * History of a documented thromboembolic event (including TIA) within the past 12 months, or history of a documented left atrial appendage (LAA) thrombus * History of a documented symptomatic lacunar infarction within the past 12 months * Previous PCI/MI within the past 2 months * Coronary Artery Bypass Grafting (CABG) surgery within past 6 months * Valvular surgery, cardiac surgery (e.g., ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure * Unstable angina pectoris within the past 6 months * Anticipated cardiac transplantation, cardiac surgery or other major surgery within the next 12 months * Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Known significant PV anomaly that in the opinion of the investigator would preclude enrollment in this study * Has known pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * Acute illness, active systemic infection or sepsis * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Severe mitral regurgitation (Regurgitant volume 60 mL/beat, Regurgitant fraction 50%, and/or Effective regurgitant orifice area 0.40cm\^2) * Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) LAAO device or other implanted metal cardiac device within the cardiac space that may interfere with the energy field created during the ablation procedure. * Presence of a condition that precludes vascular access (such as IVC filter) * Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study * Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * History of massive hemorrhage within the past 6 months * Presenting contra-indications for the devices

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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.

Contacts and locations

Locations

  • Canberra Heart Rhythm

    Garran, 2605, Australia

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4, Canada

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8, Canada

  • Royal Prince Alfred Hospital

    Camperdown, 2050, Australia

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Westmead Hospital

    Westmead, 2145, Australia

More trials for these conditions

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