Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 90

How the type of sedation affects recovery after TAVR

Official title: Patient Quality of Recovery After TAVR With Different Sedation Regimens

Run by Endeavor Health · NCT07556523 · Data updated 2026-11-12

This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

More Aortic Valve Stenosis trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment126 (estimated)
SponsorEndeavor Health
Academic / other
Locations1 site (Glenview, Illinois)
StatusRecruiting
StartedMarch 16, 2026
Main results expectedApril 2028
Study endsJune 2028
Registry record updatedApril 29, 2026
Trial IDNCT07556523 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–90 undergoing transfemoral TAVR under monitored anesthesia care who can consent in English or Spanish and have no contraindications to the study drugs are ideal candidates.

Probably not a fit

Patients with preoperative bradycardia or significant arrhythmias, conduction blocks without a pacer, very high pulmonary pressures, morbid obesity, pregnancy, or allergies to the study drugs are excluded and unlikely to benefit from this comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, Phase 4 trial enrolling adults scheduled for transfemoral TAVR under monitored anesthesia care who can consent in English or Spanish. Participants are randomly assigned to receive propofol, dexmedetomidine, or midazolam with fentanyl during the procedure. Researchers collect short patient-reported surveys on postoperative days 1 and 7 about pain, overall recovery experience, and satisfaction with anesthesia. The primary focus is differences in quality of recovery on the first day after the procedure.

Why it matters

Potential benefit: If successful, the results could help clinicians choose a sedation approach that improves early comfort, pain control, and patient satisfaction after TAVR.

How similar studies have gone: Previous research has compared conscious sedation versus general anesthesia for TAVR, but direct randomized comparisons among propofol, dexmedetomidine, and midazolam/fentanyl specifically for day‑one recovery are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

  • Endeavor Health
    Glenview, Illinois, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • CHATEAU Registry: Real-world outcomes after TAVR

    This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

    Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

  • Using 4D Flow MRI to characterize left ventricular failure

    This project will test whether automated 4D Flow MRI analysis can measure left ventricular dysfunction in adults with severe aortic stenosis who are scheduled for TAVR.

    Recruiting at 2 sites IRCCS Policlinico S. Donato · San Donato Milanese and 1 other locations · NCT07455292

  • Tracking progression and consequences of heart valve disease

    This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

    Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

  • Using Ticagrelor or Aspirin for Patients After Aortic Valve Implantation

    This study tests whether Ticagrelor works better than Aspirin to prevent blood clots and complications in adults with severe aortic stenosis after they have a heart valve replacement.

    Recruiting Phase 4 Fundacin Biomedica Galicia Sur · Vigo, Pontevedra · NCT05283356

  • Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

    This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

    Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

  • Vericiguat to slow calcific aortic valve narrowing

    This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

    Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.