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New combo heart procedure aims to cut stroke risk and improve heart function in AF patients

NCT ID NCT07453940

Disease control Sponsor: Sir Run Run Shaw Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether combining two procedures—closing the left atrial appendage and using pulsed field ablation to correct heart rhythm—works better than closing the appendage alone in people with persistent atrial fibrillation and high stroke risk. Fifty participants will be randomly assigned to one of the two groups and followed for six months. The goal is to see if the combination improves exercise capacity and blood flow to the brain.

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) using the FARAPULSE system
What this could lead to
If it works, this could point toward a better treatment strategy for persistent atrial fibrillation patients at high risk of stroke, potentially improving heart function and quality of life.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to everyone. The combination procedure also carries risks like bleeding, infection, or heart rhythm problems.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Subjects diagnosed with persistent AF with duration more than 3 months. 3. Subjects with AFEQT score \>70 . 4. Subjects with CHA2DS2-VA score ≥2. 5. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study. Exclusion Criteria: 1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes. 2. Subjects with the history of AF ablation, LAA surgically closed or otherwise excluded or the LAA anatomy does not accommodate a Closure Device. 3. Left atrial anteroposterior diameter ≥ 5.5 cm. 4. Heart failure with a NYHA III/IV and/or LVEF ≤35% within 3 months prior to the procedure. 5. Any of the following events within 90 days of the Consent Date: * Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery * Pericarditis or symptomatic pericardial effusion * Gastrointestinal bleeding * Stroke, TIA, or intracranial bleeding or any non-neurologic thromboembolic event 6. Contraindication to, or unwillingness to use systemic anticoagulation. 7. Subjects with contraindications or not tolerate to EP procedure, general anaesthesia, or the tests included in the study, like CPET, MRI. 8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia. 9. Women of childbearing potential who are pregnant or lactating. 10. Renal insufficiency if an eGFR is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant. 11. Predicted life expectancy is less than 12 months.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial appendage closure for atrial fibrillation Pfa ablation and laac procedures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.