Pulsed electric fields take aim at irregular heartbeats
NCT ID NCT07811934
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Researchers are testing a cardiac pulsed field ablation system that uses a spherical catheter to treat symptomatic, recurrent paroxysmal atrial fibrillation that has not responded to drugs. The trial enrolls 284 adults and randomly assigns them to either the investigational pulsed field ablation or standard radiofrequency ablation. The main goal is to see whether the new system keeps participants free from atrial fibrillation at 12 months without needing additional procedures or antiarrhythmic drugs, and to track safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pulsed field ablation system with a spherical ablation catheter
- What this could lead to
- If it works, this could offer a different way to treat paroxysmal atrial fibrillation, using pulsed electric fields instead of heat or cold to isolate the pulmonary veins.
- What could go wrong
- The trial may show the new device is not as good as standard radiofrequency ablation, or it may cause complications. As a non-inferiority study, it only aims to match, not beat, the existing treatment.
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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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About 284 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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 75 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: * Age ≥18 years and ≤75 years, without gender restriction * Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation * Subjects scheduled for atrial fibrillation catheter ablation * Subjects who agree to participate in this study and voluntarily sign the informed consent form Exclusion Criteria: * Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes * Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm * Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation * Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device * Prior or planned concomitant left atrial appendage closure procedure at index procedure * Diagnosis of hypertrophic cardiomyopathy * History of congenital heart disease with residual anatomical or conduction abnormalities * Hemodynamically significant valvular heart disease judged by investigator to be ineligible for enrollment * Prior valve repair or valve replacement surgery * Implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device * NYHA functional class Ⅲ-Ⅳ * Left ventricular ejection fraction (LVEF) ≤40% * Symptomatic hypotension or uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg in two baseline measurements) * Symptomatic resting bradycardia or type-second-degree or third-degree atrioventricular block * Contraindication to systemic anticoagulation, or unwillingness to receive systemic anticoagulation * Medical conditions that may interfere with study participation, assessment or treatment, significantly increase study-related risk, or alter study outcomes, including but not limited to: moderate-to-severe COPD, moderate-to-severe pulmonary hypertension, or diseases causing severe dyspnea or resting hypoxemia; renal insufficiency (eGFR\<30 ml/min/1.73 m²) or history of hemodialysis or renal transplantation; active malignancy or treated malignancy within 24 months prior to enrollment (excluding basal cell or squamous cell skin carcinoma); active systemic infection * Myocardial infarction, unstable angina, heart failure hospitalization within 3 months prior to enrollment; any cardiac interventional or open-heart surgery within 1 month prior to enrollment (coronary angiography excluded) * Stroke (excluding silent stroke), transient ischemic attack or any thromboembolic event within 3 months prior to enrollment * Expected survival less than 1 year * Female subjects who are pregnant, lactating, or planning pregnancy during study period * Participation in another interventional device clinical trial within 1 month before enrollment, or within 5 half-lives of last study drug for drug clinical trials * Any other condition judged by investigator to make the subject unsuitable for this clinical trial
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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 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.
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Other studies related to the condition(s) this trial covers.
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