Ablation without X-Rays: a new way to fix irregular heartbeats?
NCT ID NCT07762742
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether a heart procedure called pulsed field ablation can be guided using only ultrasound, avoiding the use of X-rays (fluoroscopy), in people with paroxysmal atrial fibrillation. The study compares the success of completely isolating the pulmonary veins—a key step in the procedure—between ultrasound-only and standard fluoroscopy guidance. If ultrasound works just as well, it could reduce radiation exposure for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous pulsed field ablation (PFA) procedure
- What this could lead to
- If ultrasound-only guidance works as well as fluoroscopy, it could make PFA safer by eliminating radiation exposure during the procedure.
- What could go wrong
- This is an early-stage comparison, and ultrasound guidance may not be as effective or safe in all patients. The trial is non-inferiority, so it only aims to show it's not worse, not better.
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 276 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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.
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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: * Adult patients aged 18 to 75 years (including 18 years and 75 years of age). * Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation. * Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program. Exclusion Criteria: * Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes; * Previous history of catheter ablation or cardiac surgery for atrial fibrillation; * Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair; * Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials; * Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.); * Persistent atrial fibrillation; * Left atrial anteroposterior diameter (LAD) \> 55 mm on transthoracic echocardiography; * Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial; * Current participation in another pharmaceutical or medical device clinical study.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new catheter zap away irregular heartbeats?
- Which imaging guide leads to better outcomes in heart ablation?
- Smart pacemaker aims to catch and stop heart flutter before it starts
- New heart zapping technique could free patients from irregular rhythm
- New heart zapping device could free patients from irregular heartbeat