NCT04107038

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-11-22
• Primary completion: 2025-07-15
• Completion: 2025-08-15
• First posted: 2019-09-27
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States