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New heart procedure aims to keep veins isolated longer

NCT ID NCT07236619

Disease control Sponsor: Erasmus Medical Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests a new device called the VariPulse catheter, which uses short electrical pulses to treat atrial fibrillation (AF), a common heart rhythm problem. Twenty adults with AF will get this treatment, and after 2-3 months, doctors will check if the treated veins are still isolated. The goal is to see how durable the treatment is and whether it can prevent AF from coming back.

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 with the VariPulse catheter
What this could lead to
If successful, this could show that the VariPulse system durably isolates pulmonary veins, potentially improving long-term control of atrial fibrillation.
What could go wrong
This is a small, early study with only 20 patients. It is designed to check reconnection rates, not to prove long-term effectiveness or safety. The procedure still carries risks like bleeding or heart damage.

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 20 people

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

Started

Sep 2025

Expected to finish

May 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: * History of symptomatic paroxysmal AF * Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF * Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure * Participants whose age is 18-80 years. * Participants who are willing and capable of providing informed consent. Exclusion Criteria: * Any known contraindication to an AF ablation or anticoagulation * History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia * AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause * Significant structural heart disease * History of blood clotting or bleeding disease * Severe kidney disease (glomerular filtration rate \<30 ml/min/1.73 m2) * Stroke or transient ischemic attack \<3 months prior to enrollment * Active systemic infection * Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study * Participants who are currently enrolled in another investigational study or registry that would directly interfere with the current 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.

Paroxysmal af

Contacts and locations

Locations

  • Erasmus MC

    Rotterdam, South Holland, Netherlands

More trials for these conditions

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