New heart catheter shows promise for stopping AFib episodes
NCT ID NCT06272981
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.
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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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135 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Oct 2025
- Lead sponsor
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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
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18 to 80 years
- 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.
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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
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Canberra Heart Rhythm
Garran, 2605, Australia
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McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
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Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
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Royal Prince Alfred Hospital
Camperdown, 2050, Australia
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Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
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University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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Westmead Hospital
Westmead, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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