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Anesthesia Types for TAVR

N/A
Recruiting
Led By George Whitener, M.D.
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
Adult patients who are medically eligible to receive both anesthetics (GA and MAC)
Must not have
Inability to lie flat
Patients with any of the following absolute contraindications to TEE: Perforated Viscus, Esophageal Stricture, Esophageal Tumor, Esophageal Perforation, Esophageal Diverticulum, Active upper GI Bleed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month
Awards & highlights

Summary

This trial is studying the effects of two types of anesthesia on people undergoing a heart valve replacement procedure.

Who is the study for?
Adults over 18 needing a TAVR for aortic valve stenosis and can receive both general anesthesia (GA) and monitored anesthesia care (MAC). Excluded are those who don't speak English, have BMI >37, difficult airways, pregnant women, unable to consent, allergic or with contraindications to the anesthetics or TEE.
What is being tested?
The study compares two types of anesthesia in patients undergoing TAVR: MAC versus GA. It looks at hospital stay length, ICU admission rates, procedural mortality and if using TEE during GA affects device success.
What are the potential side effects?
Potential side effects may include typical risks associated with anesthesia such as nausea, vomiting, sore throat from intubation under GA; less sedation-related issues like drowsiness or confusion might be expected with MAC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult getting a valve replacement through my thigh for a narrowed heart valve.
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I can safely receive general and monitored anesthesia care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot lie flat.
Select...
I do not have conditions like esophageal issues or active upper GI bleeding that prevent TEE.
Select...
I've needed a special procedure for intubation due to a difficult airway.
Select...
I am currently pregnant.
Select...
I cannot speak English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital Length of Stay
ICU Admission Rate
Procedural Mortality
Secondary study objectives
Paravalvular Regurgitation

Trial Design

2Treatment groups
Active Control
Group I: SedationActive Control1 Intervention
Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.
Group II: GeneralActive Control1 Intervention
Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
960 Previous Clinical Trials
7,399,390 Total Patients Enrolled
George Whitener, M.D.Principal Investigator - Medical University of South Carolina - Department of Anesthesia
MUSC Children's Hospital, Medical University of South Carolina

Media Library

General Endotracheal Anesthesia Clinical Trial Eligibility Overview. Trial Name: NCT04107038 — N/A
Transcatheter Aortic Valve Replacement Research Study Groups: Sedation, General
Transcatheter Aortic Valve Replacement Clinical Trial 2023: General Endotracheal Anesthesia Highlights & Side Effects. Trial Name: NCT04107038 — N/A
General Endotracheal Anesthesia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04107038 — N/A
~23 spots leftby Jun 2025
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