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New wire under the microscope: could savvywire improve TAVI outcomes?

NCT ID NCT07366671

Knowledge-focused Sponsor: dr Pim A.L. Tonino Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 watches which guidewires doctors use during a minimally invasive heart valve replacement (TAVI) and checks if a newer wire, the Savvywire, works better. About 300 people aged 50 or older getting TAVI through the groin will take part. Researchers will collect data from normal care to compare the wires' performance, safety, and how they affect the procedure.

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.

Participants

About 300 people

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

Started

Jan 2026

Expected to finish

Mar 2028

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.

Who is studied

All patients eligible for participation in this registry are aged ≥50 years old presenting with symptomatic severe aortic valve stenosis and accepted for transfemoral TAVI procedure after consultation in the Heart team and TAVI team. A pre-procedural CT scan for TAVI sizing is required as standard of care. Both balloon-expandable and self-expandable TAVI platforms are allowed. Valve-in-valve procedures and procedures in bicuspid aortic valve anatomy can be included.

Ages

50 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: * Age ≥ 50 years * Accepted for transfemoral TAVI procedure by Heart team and TAVI team * Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform * Ability to understand and the willingness to provide written informed consent * Patients scheduled for valve-in-valve procedures can be included * Patients with bicuspid anatomy can be included Exclusion Criteria: * Patients planned for a non-transfemoral TAVI procedure * Extremely horizontal aorta (aortic root angle \>70 degrees) * Extreme tortuosity at the level of the iliofemoral arteries, abdominal and/or thoracic aorta * Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder aortic valve stenosis

As listed by the trial registrant

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

Aortic valve disease Tavi(transcatheter aortic valve implantation)

How to take part

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

  1. The places running it

    1 site. 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

  • Catharina Hospital Eindhoven

    RECRUITING

    Eindhoven, North Brabant, 5623EJ, Netherlands

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