New heart device tested in japan: no leads inside the heart

NCT ID NCT07091916

Completed Disease control Sponsor: Medtronic Cardiac Rhythm and Heart Failure Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study tested a new type of implantable defibrillator (EV ICD) in 14 Japanese patients with dangerous heart rhythms. The device is placed under the skin, outside the heart and blood vessels, to deliver a shock if a life-threatening rhythm occurs. Researchers checked if the device could safely stop induced abnormal rhythms and whether there were any major complications within two weeks of implant.

What this could mean

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

Active substance: Extravascular implantable cardioverter defibrillator (EV ICD) device
What this could lead to: If successful, this device could offer a new way to protect people at risk of dangerous heart rhythms without leads inside the heart or blood vessels.
What could go wrong: This was a very small, early study in just 14 people, so results may not apply to everyone. The device is still new and long-term safety and performance are not yet fully known.

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

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease Tachycardia

As listed by the trial registrant

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

TACHYCARDIA VENTRICULAR ARRYTHMIA

Contacts and locations

Locations

Medtronic Japan Co., Ltd.

Tokyo, 1080075, Japan

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