New balloon zaps heart rhythm problem in first human test

NCT ID NCT06828939

Recruiting now Disease control Sponsor: CardioFocus Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This early study tests a new balloon device that uses pulsed electric fields to treat atrial fibrillation, a common heart rhythm disorder. 75 people with short-duration AF who haven't had prior ablation will receive the procedure and be followed for one year. The goal is to see if the device can safely isolate the pulmonary veins and prevent arrhythmia recurrence.

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 balloon device
What this could lead to: If successful, this could offer a safer, more effective way to treat atrial fibrillation with a single procedure, reducing the need for repeat treatments.
What could go wrong: This is a very early first-in-human study with only 75 people. The procedure carries risks like heart perforation, stroke, or nerve injury. Long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ATRIAL FIBRILLATION (PAROXYSMAL) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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 (PAROXYSMAL)

Contacts and locations

Locations

Na Homolce Hospital
RECRUITING

Prague, Czech Republic, Czechia

More trials for these conditions

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