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Heart procedure upgrade: could extra ablation stop AFib return?

NCT ID NCT07191626

Disease control Sponsor: Changhai 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 This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two heart procedures for people with paroxysmal atrial fibrillation (AFib), a condition where the heart beats irregularly. One group gets standard ablation to isolate the pulmonary veins, while the other also gets ablation of the superior vena cava using pulsed field energy. Researchers will track 650 participants for 12 months to see if the extra step reduces AFib recurrence without causing more complications.

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 procedure
What this could lead to
If successful, this could offer a more effective ablation strategy for paroxysmal atrial fibrillation, reducing the chance of irregular heartbeats returning.
What could go wrong
This is an early-stage trial with 12-month follow-up, so long-term benefits are unknown. Adding extra ablation may increase risks like nerve injury 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 650 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 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 to 80 years

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. Documented paroxysmal AF (episodes self-terminating within 7 days), evidenced by ECG, Holter, or event monitor 2. Age between 18 and 80 years 3. Willing and able to provide written informed consent Exclusion Criteria: 1. Intracardiac thrombus (left atrium or left atrial appendage) 2. Left atrial anterior-posterior diameter \> 60 mm 3. Absolute contraindication to anticoagulation therapy 4. Stroke or myocardial infarction within 1 month prior to enrollment 5. Uncontrolled hyperthyroidism 6. Pregnancy or planning pregnancy 7. Life expectancy less than 1 year 8. Previous atrial fibrillation ablation procedure 9. Known or suspected AF triggers primarily originating from the SVC (based on pre-procedure mapping, if available) 10. Inability or unwillingness to participate in the study or comply with follow-up requirements

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation Paroxysmal atrial fibrillation (PAF)

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital). No. 168, Changhai Road, Yangpu District, Shanghai, China.

    Shanghai, Shanghai Municipality, 200040, China

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