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Heart fix without X-Ray: new study tests safer ablation for AFib

NCT ID NCT06719921

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 2 times

Summary

This study compares two ways of doing a heart procedure called catheter ablation for people with atrial fibrillation (an irregular heartbeat). One method uses X-rays to guide the doctor, and the other does not. The goal is to see if the no-X-ray method works just as well and is as safe. About 724 adults aged 18 to 80 with AFib will take part, and the main focus is on whether their heart rhythm stays normal for a year after the procedure.

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 724 people

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

Started

Apr 2025

Expected to finish

May 2028

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 2. Patients diagnosed with paroxysmal AF or persistent AF with a duration of 1 years or less, who are referred for catheter ablation. 3. Patients referred for catheter ablation as a first-time intervention (no prior catheter ablation or surgical procedures for AF). 4. The patient is able and willing to provide written informed consent. Exclusion Criteria: 1. Patients with contraindication to anticoagulation 2. Patients with contraindication to right or left sided cardiac catheterization 3. X-ray fluoroscopy is required in the procedure, such as ablation combined with VOM ethanol ablation, epicardial ablation, LAAO, CAG, etc. 4. Serious known concomitant disease with a life expectancy of \< 1 year 5. MI, CABG, or PCI within the preceding 3 months 6. Left atrial diameter \>55 mm 7. LVEF\<30% 8. NYHA class III or IV 9. Awaiting cardiac transplantation or other cardiac surgery within 12 months. 10. History of a documented thromboembolic event within the past 6 weeks. 11. Heart or vascular malformation that impedes catheter access or vascular puncture. 12. Current enrollment in an investigational study evaluating another device or drug. 13. Acute illness, active systemic infection, or sepsis. 14. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF)

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.