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Patient Quality of Recovery After TAVR With Different Sedation Regimens

Patient Quality of Recovery After TAVR With Different Sedation Regimens

Recruiting
18-90 years
All
Phase 4

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Overview

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.

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

Eligibility

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

Study details
    Transcatheter Aortic Valve Replacement (TAVR)
    Aortic Valve Stenosis

NCT07556523

David Lyubashevsky

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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