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New TAVI technique may skip balloon step, improving safety

NCT ID NCT02729519

Disease control Sponsor: University Hospital, Montpellier 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether implanting a new aortic valve (TAVI) without first using a balloon to open the narrowed valve is safer and as effective as the standard procedure with balloon predilatation. 250 adults with severe aortic stenosis who were at high risk for open-heart surgery took part. The goal was to see if skipping the balloon step reduces complications while still achieving a successful valve implant.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

250 people

The number who actually took part.

Started

Jun 2016

Finished

Aug 2018

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: * Symptomatic Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2) * Males or females of at least 18 years of age * Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team * Signed informed consent * TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience) Exclusion Criteria: * Transapical TAVI * Preexisting aortic prosthesis (valve in valve technique) * Vascular conditions that make insertion and endovascular access to the aortic valve impossible * BAV performed for less than one week * Recent myocardial infarction (STEMI within the last 3 months) * Left ventricular or atrial thrombus by echocardiography * Mitral or tricuspidal valvular insufficiency (\> grade II) * Evolutive or recent cerebrovascular event (within the last 3 months) * Symptomatic carotid or vertebral arterial narrowing (\>70%) disease * Bleeding diathesis or coagulopathy or patient refusing blood transfusion * Lack of written informed consent, severe mental disorder, drug/alcohol addiction * Life expectancy \< 1 year * Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, or sensitivity to contrast media that cannot be adequately premedicated * Participation in another drug or device study that would jeopardize the appropriate analysis of end-points of this study. * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Pregnancy

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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 valve stenosis

Contacts and locations

Locations

  • University hospital of Montpellier

    Montpellier, 34295, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.