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Heart valve study: is being awake or asleep better during procedure?

NCT ID NCT04347603

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 218 people with severe aortic stenosis (a narrowed heart valve) who needed a procedure called TAVI to replace the valve without open-heart surgery. Researchers compared two approaches: general anesthesia (being fully asleep) versus local anesthesia with sedation (being awake but relaxed). The goal was to see if general anesthesia was as safe and effective as the lighter sedation method, focusing on complications and recovery within the first 72 hours.

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

218 people

The number who actually took part.

Started

Dec 2020

Finished

Mar 2024

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 to 80 years

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: * Patients over 18 years of age * Consecutive patients referred to the cardiology department of the CHU in Montpellier, France, for TAVI via transfemoral access. * Patients for whom the procedure is indicated after decision by the heart team and according to the current recommendations of the European Society of Cardiology. * Patients with severe aortic stenosis defined by mean gradient \> 40 mmHg and/or aortic valve area 1 cm2 or 0.8 cm2/m2 as recommended. May also include patients with low gradient (\< 40mm hg) and low flow (stroke volume index \< 35ml/minute) which are classic indications for aortic valve replacement * Ability to consent to participate in study * Patient affiliated with or beneficiary of a social security scheme Exclusion Criteria: * Chronic respiratory insufficiency treated by long term oxygeno therapy * Pulmonary hypertension above 50mmHg * BMI\>35 * TAVI by carotidian or apical way * Pregnant women * Vulnerable person according to L1121-6 of Public Health reglementation in France

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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.

Stenoses, aortic

Contacts and locations

Locations

  • University hospital

    Montpellier, France

  • University hospital

    Nîmes, France