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

NCT04107038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-09-16

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

General Endotracheal Anesthesia

Participants receive general endotracheal anesthesia for the procedure, as well as analyzing the information from their transesophageal echocardiography per routine clinical care.

PROCEDURE

Monitored anesthesia care

Participants receive monitored anesthesia care for their procedure.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2025-07-15
Completion
2025-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107038 on ClinicalTrials.gov