New device aims to seal off stroke risk without blood thinners

NCT ID NCT06580275

Ongoing Disease control Sponsor: Conformal Medical, Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called CLAAS that is implanted in the heart to close off a small pouch (the left atrial appendage) where blood clots often form in people with atrial fibrillation. The goal is to reduce the risk of stroke without needing long-term blood thinners. About 80 adults with atrial fibrillation and a high stroke risk who cannot take blood thinners will receive the implant, and doctors will check if the device seals properly and is safe after 45 days.

What this could mean

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

Active substance: CLAAS device (a heart implant to close the left atrial appendage)
What this could lead to: If successful, this device could offer a safer, drug-free way to prevent strokes in people with atrial fibrillation who cannot use blood thinners.
What could go wrong: This is an early-stage study with only 80 participants and no comparison group, so results may not apply broadly. Risks include heart injury, stroke, bleeding, or the device not sealing properly.

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.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

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

ATRIAL FIBRILLATION STROKE PREVENTION

Contacts and locations

Locations

Aarhus University Hospital, Skejby

Aarhus, DK-8200, Denmark
Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy
Na Homolce Hospital

Prague, 150 30, Czechia
University Hospital of Copenhagen

Copenhagen, DK-2100, Denmark

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