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Electric zaps to the heart: a new hope for stubborn AF?

NCT ID NCT06128174

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called the Farawave catheter, which uses electrical pulses to destroy heart tissue causing long-standing atrial fibrillation. Twenty adults with this condition for over a year will undergo the procedure. The goal is to see if it stops abnormal heart rhythms for at least a year.

What this could mean

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

Active substance
Farawave PFA catheter (device that uses electrical energy to destroy heart tissue causing abnormal signals)
What this could lead to
If successful, this could offer a new, safer way to control long-standing atrial fibrillation and reduce the need for lifelong medication.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply to everyone. The procedure carries risks like bleeding, infection, 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

20 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 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 years * Long-standing Persistent AF (\>1 year continuous AF) * Planned for a first-ever AF ablation procedure * Left ventricular ejection fraction \>30% (as assessed within 6 months of randomization) Exclusion Criteria: * Prior left atrial ablation or left atrial surgery (including mitral valve surgery) * Hypertrophic cardiomyopathy * Major cardiac surgery within 6 months preceding the consent date * Within 3 months preceding the consent date: * Stroke, TIA, intracranial bleeding * Any thromboembolic event * Carotid stenting or endarterectomy * Life expectancy less than one year

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Long-standing persistent af

Contacts and locations

Locations

  • Mount Sinai Hospital

    New York, New York, 10029, United States