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

NCT ID NCT06818006

Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team * Obtained informed consent Exclusion Criteria: * Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization * Hostile aortic root on CT for TAVI implantation defined by, but not limited to: * High risk LVOT with a dimension significantly smaller than the annulus and/or extensive calcification * Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and/or shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG) * High risk STJ anatomy defined by inadequate height and/or diameter and/or excessive calcification * Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and/or unfolded aorta and/or extensive tortuosity and/or excessive iliofemoral calcification) * GFR \<15, excluding patients on dialysis * Life expectancy less than 3 years * Any factor precluding 1-year follow-up

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mazankowski Heart Insitute

    Edmonton, Alberta, T6G 2B7, Canada

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9, Canada

More trials for these conditions

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