Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

Description

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Conditions

Transcatheter Aortic Valve Replacement

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Study Overview

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Study Details

Study overview

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement

Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

Condition
Transcatheter Aortic Valve Replacement
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Medical University of South Carolina,

George Whitener, M.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina - Department of Anesthesia

Study Record Dates

2025-12-31