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Lighter anesthesia may speed recovery after heart valve procedure

NCT ID NCT04107038

Symptom relief Sponsor: Medical University of South Carolina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether using lighter sedation (monitored anesthesia care) instead of general anesthesia with a breathing tube could help people recover faster after a minimally invasive heart valve replacement called TAVR. The trial included 170 adults getting TAVR through a leg artery. Researchers measured how long people stayed in the hospital, whether they needed intensive care, and safety outcomes like death within 30 days.

What this could mean

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

Active substance
Anesthesia (monitored anesthesia care vs. general endotracheal anesthesia)
What this could lead to
If MAC works as well as general anesthesia, it could mean shorter hospital stays and fewer ICU admissions for TAVR patients.
What could go wrong
This is a single-center study with 170 participants, so results may not apply to all hospitals or patients. The choice of anesthesia depends on individual medical needs.

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

170 people

The number who actually took part.

Started

Nov 2019

Finished

Aug 2025

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

Accepted

You do not need to have the condition being studied to take part.

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: * Adult patients ≥ 18 years old * Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis * Adult patients who are medically eligible to receive both anesthetics (GA and MAC) Exclusion Criteria: * Inability to speak English * Body Mass Index (BMI) \> 37 kg/m2 * History of difficult airway requiring fiberoptic intubation * Inability to lie flat * Women who are pregnant * Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study. * Inability or unwillingness of subject to give informed consent based on any reason * Patients with any of the following absolute contraindications to TEE: * Perforated Viscus * Esophageal Stricture * Esophageal Tumor * Esophageal Perforation * Esophageal Diverticulum * Active upper GI Bleed

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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.

Transcatheter aortic valve replacement

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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