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New heart catheter zaps away irregular rhythms without heat or cold

NCT ID NCT06056557

Disease control Sponsor: Vivek Reddy 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new catheter system that uses pulsed field energy to treat atrial fibrillation and related arrhythmias. In 141 patients, doctors used the VARIPULSE catheter with a 3D mapping system to destroy the heart tissue causing the irregular rhythm. The goal was to see if the procedure is safe and effective at stopping the abnormal signals.

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 device
What this could lead to
If successful, this could offer a safer and more precise way to treat atrial fibrillation using pulsed field energy instead of heat or cold.
What could go wrong
This is a small, completed study without a control group, so results may not apply to all patients. The procedure still carries risks like any heart ablation.

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

141 people

The number who actually took part.

Started

Sep 2023

Finished

Apr 2025

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: * Age 18 or older. * Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA). * Previous surgical or catheter ablation for atrial fibrillation is allowed * Planned for a catheter ablation procedure * Able and willing to provide written consent and comply with all testing and follow-up requirements * Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm Exclusion Criteria: * Documented "active" left atrial thrombus * Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.) * Previous PCI/MI within the past 1 month * Active systemic infection or sepsis * Uncontrolled heart failure - New York Heart Association (NYHA) function class IV. * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment. * Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial. * Life expectancy or other disease processes likely to limit survival to less than 12 months. * Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter

As listed by the trial registrant

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

Atrial fibrillation and flutter Atrial fibrillation, paroxysmal or persistent Atrial flutter typical

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

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