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Taking people in United StatesPhase 4

Comparing sedation medicines for recovery after aortic valve replacement through a catheter

Compares sedation medicines during valve replacement for aortic valve stenosis.

Key facts

Who runs it
David Lyubashevsky
Where
Glenview, United StatesSee the site
Trial code
Registry title
Patient Quality of Recovery After TAVR With Different Sedation Regimens
Status
Recruiting
Phase
Phase 4
People taking part
126 people, planned
Started
16 Mar 2026
Expected to end
Jun 2028
Type of study
Interventional, 3 groups
Treatments tested
  • Propofol
  • Dexmedetomidine
  • Midazolam
  • Fentanyl
Record updated
29 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults having a TAVR heart valve procedure through the groin artery with light sedation. It compares three sedation drugs and how people recover.

Age
18 to 90 years
Sex
All
Disease stage
Aortic valve stenosis (narrowed heart valve), with a planned transfemoral TAVR under Monitored Anesthesia Care (MAC).

Main reasons for not taking part

  • Heart rate below 50 bpm before the procedure, or irregular heart rhythm such as AFib with RVR
  • Heart conduction problems such as 2nd/3rd degree AV block without a pacemaker
  • Allergy to the study drugs, or a reason they cannot be used
  • Pulmonary artery pressure above 70mmHg, or BMI above 50
  • Pregnancy, or unable to give consent in English or Spanish

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 18-90 years old, inclusive
  • Undergoing transfemoral TAVR under Monitored Anesthesia Care (MAC)
  • Speaks English or Spanish
  • Consents to participate

Who cannot take part

  • Preoperative heart rate < 50 bpm or arrhythmias (e.g., AFib with RVR)
  • Allergy or contraindication to study drugs
  • Conduction abnormalities (e.g., 2nd/3rd degree AV block without pacer)
  • Pulmonary artery pressure > 70mmHg
  • Morbid obesity BMI > 50
  • Pregnancy
  • Unable to consent in English or Spanish

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Where in United States

  • Endeavor HealthGlenview, United StatesContact: Jessica BricknerTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to learn whether the type of sedation medication used during a transcatheter aortic valve replacement (TAVR) affects how people recover after the procedure. The main question this study aims to answer is whether different sedation regimens (propofol, dexmedetomidine, or midazolam with fentanyl) lead to differences in quality of recovery on the first day after the procedure.

Read full original descriptionShow less

Researchers will compare three commonly used sedation medications (propofol, dexmedetomidine, or midazolam with fentanyl) to determine whether they lead to differences in recovery following a TAVR.

Participants will:

* Be enrolled before their scheduled TAVR procedure * Be randomly assigned to receive one of the three sedation medications during their procedure * Complete short surveys on postoperative days 1 and 7 about pain levels, how they feel during their recovery, and how satisfied they were with their anesthesia experience

The 3 groups in the trial

  • PropofolTreatment being tested

    Participants will receive propofol for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

  • DexmedetomidineTreatment being tested

    Participants will receive dexmedetomidine for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

  • Midazolam and FentanylTreatment being tested

    Participants will receive a combination of midazolam and fentanyl for intraoperative sedation during transcatheter aortic valve replacement (TAVR).

    Treatment: Midazolam and Fentanyl

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Patient Quality of Recovery After TAVR With Different Sedation Regimens
Plain-language title
Comparing sedation medicines for recovery after aortic valve replacement through a catheterGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07556523, who can take part
Record updated
29 April 2026