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New heart ablation technique aims to tame irregular heartbeats

NCT ID NCT07511166

Disease control Sponsor: Johnson & Johnson Medical (Shanghai) Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 5 times

Summary

This study tests a catheter-based procedure called Varipulse to treat paroxysmal atrial fibrillation (irregular heartbeat that comes and goes). Researchers want to see how well it works long-term when combined with different types of sedation. About 300 adults aged 18-80 with symptoms despite medication will be enrolled. The goal is to improve heart rhythm control and reduce the need for repeat procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Varipulse catheter ablation procedure
What this could lead to
If successful, this could improve the standard of care for atrial fibrillation ablation, leading to better long-term control of irregular heartbeats.
What could go wrong
This is an early-stage study with 300 participants, not yet recruiting. The procedure carries risks like bleeding, infection, or heart damage, and results may not apply to all patients.

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.

Participants

About 300 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include participants diagnosed with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF) or who are intolerable to class I and/or III antiarrhythmic drugs (AAD) based on medical records.

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: * Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records * Age 18-80 years * Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements * Signed patient informed consent form (ICF) Exclusion criteria: * Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause * Previous left atrium (LA) ablation or surgery * Left atrium diameter (LAD) greater than (\>) 50 millimeters (mm) by transthoracic echocardiography (TTE) * Left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%) * Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU) * Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access * Other conditions that, at discretion of the investigators, would preclude enrollment in this study

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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.

Atrial fibrillation

How to take part

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

  1. 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 ↗

  2. 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.