Heart zapping study checks if AFib fix lasts
NCT ID NCT07620262
First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study looks at whether pulsed field ablation (PFA), a standard treatment for atrial fibrillation, creates lasting changes in the heart's electrical pathways. Researchers will check this during a follow-up procedure to close the left atrial appendage, and may do extra ablation if needed. About 50 adults with AFib and a high stroke risk are being enrolled.
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 (PFA) and left atrial appendage occlusion (LAAO) device
- What this could lead to
- If successful, this could confirm that PFA provides lasting isolation of faulty heart signals, potentially reducing the need for repeat procedures in atrial fibrillation patients.
- What could go wrong
- This is a small, early-stage study (50 participants) with no control group, so results may not apply broadly. The procedure itself carries risks like bleeding, infection, or heart rhythm issues.
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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- 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: * Participant is ≥ 18 years of age, or older if specified by local law * Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause * Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction * Participant has a CHADSVASc\>=3 in women and \>=2 in men * There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection * Participant is willing and capable of providing informed consent * Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center Exclusion Criteria: * Participant has had prior AF ablation (including surgical ablation) * Participant has had prior left atrial appendage occlusion or closure * Participant has an intracardiac mass or thrombus * Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation * Participant has a life expectancy \< 1 year * Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days * Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits * Participant has an active systemic infection * Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis * Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach * Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels) * Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period * Participant has longstanding persistent AF ongoing for greater than 10 years * Participant has Left atrial appendage anatomy unsuitable for LAAO device * Participant has an LA diameter \>6 cm
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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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South Shore University Hospital
RECRUITINGBay Shore, New York, 11706, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke