Can TAVI be done safely without a surgery team on standby?

NCT ID NCT06818006

Not yet recruiting Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

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

Summary

This study looks at whether a common heart valve procedure called TAVI is safe when done in hospitals that don't have heart surgery available on-site. About 600 people with severe aortic stenosis will be randomly assigned to have TAVI either with or without surgical backup. The goal is to see if outcomes like death, heart attack, or stroke differ between the two groups.

What this could mean

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

Active substance: Transcatheter Aortic Valve Replacement (TAVR) procedure
What this could lead to: If successful, this could allow more hospitals to offer TAVI, making treatment more accessible for people with severe aortic stenosis.
What could go wrong: This is a Phase 4 trial, but it's still testing safety in a new setting. Without on-site surgery, emergency complications might be harder to manage, and results may not apply to all centers.

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.

aortic valve stenosis

As listed by the trial registrant

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

AORTIC STENOSIS SEVERE AORTIC STENOSIS

Contacts and locations

Locations

Mazankowski Heart Insitute

Edmonton, Alberta, T6G 2B7, Canada
Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

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