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Single-Lead ICD that spots hidden heart rhythm problems

NCT ID NCT04869527

Completed Disease control Sponsor: Biotronik SE & Co. KG Source: ClinicalTrials.gov ↗

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests a special implantable cardioverter-defibrillator (ICD) that uses a single lead to sense both heart chambers, aiming to detect atrial fibrillation and other arrhythmias early. It includes 56 people who need a single-chamber ICD and are in normal sinus rhythm at the start. The device automatically sends data to a remote monitoring center, which may help doctors manage heart conditions sooner.

What this could mean

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

Active substance
BIOTRONIK ICD with DX Technology
What this could lead to
If successful, this approach could improve early detection of atrial fibrillation and reduce complications in people with single-chamber ICDs.
What could go wrong
This is a small, early-stage study with 56 participants, so results may not apply to all patients. The device may not detect all arrhythmias or could have technical issues.

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.

Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

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

ARRHYTHMIAS, CARDIAC

Contacts and locations

Locations

  • BIOTRONIK Coml Médica LTDA

    São Paulo, 01533-000, Brazil

  • Santa Casa de Misericórdia de Porto Alegre - Brugada Institute

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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