New 'Cold' ablation device aims to zap heart rhythm problems without heat
NCT ID NCT07018596
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the CellFX nsPFA catheter, which uses short electrical pulses instead of heat to treat paroxysmal atrial fibrillation (a type of irregular heartbeat). The goal is to see if it is safe and effective at restoring normal rhythm in 215 adults who have not responded well to medication. The procedure targets the heart's pulmonary veins to block faulty signals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CellFX nsPFA Cardiac Catheter System (device using nanosecond pulsed field ablation)
- What this could lead to
- If successful, this could offer a safer, more precise way to treat atrial fibrillation without heat, potentially reducing complications and improving recovery.
- What could go wrong
- This is an early-stage device trial with 215 participants, so results may not apply to everyone. Risks include stroke, heart damage, or other serious side effects.
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 215 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- 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 85 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.
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: * A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following: i. Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment * Age 18 through 85 years old (or older than 18 if required by local law) * Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD. * Participant is willing and capable of providing Informed Consent * Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators Exclusion Criteria: * Left atrial diameter ≥5.5 cm (anteroposterior) * Any of the following within 3 months prior to enrollment: 1. Any cardiac surgery 2. Myocardial infarction 3. Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting 4. Unstable angina 5. Pericarditis or symptomatic pericardial effusion * Any of the following within 6 months prior to enrollment: 1. Any cerebral ischemic event (stroke or transient ischemic attack (TIA) 2. History of thromboembolic event * Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion) * Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period * Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure * Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure. * Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function). * Prior diagnosis of pulmonary vein stenosis * Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve). * Moderate to severe mitral valve stenosis * More than moderate mitral regurgitation (i.e., 3+ or 4+ MR) * New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE) * History of pulmonary hypertension with pulmonary systolic artery pressure \>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease * Rheumatic heart disease * Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin) * Active systemic infection * Hypertrophic or advanced infiltrative cardiomyopathy * Atrial myxoma * Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity * History of abnormal bleeding and/or clotting disorder * Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant * History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux * Solid organ or hematologic transplant, or currently being evaluated for an organ transplant * 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 * Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility) * Body Mass Index (BMI) \> 40.0 * Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder) * Life expectancy less than one year * 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 * Unwilling or unable to comply fully with study procedures and 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
1 site. 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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Na Homolce Hospital
RECRUITINGPrague, Roentgenova, 37/2, Czechia
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