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

NCT04107038 | Completed DMC

• 1 other identifier: Pro00088473
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anesthesia, TAVR, Cardiothoracic, Cardiology

Outcome Measures

Primary Outcomes (3)

• Hospital Length of Stay

  The total number of hours that the patient stayed in the hospital will be measured from the "Anesthesia Start" time until their time of discharge, as recorded in their electronic medical record.

  Up to 1 month

• ICU Admission Rate

  The investigators will determine the ICU admission rate by taking the total number of patients admitted to the ICU and dividing it by the number of cases in each arm of the study, based on MUSC's "fast track" pathway and our inclusion.

  Up to 48 hours

• Procedural Mortality

  The percentage of the study population that died within 30 days of their procedure or during index procedure hospitalization - if the postoperative length of stay is longer than 30 days.

  Up to 30 days

Secondary Outcomes (1)

• Paravalvular Regurgitation

  For GETA cases, will be recorded after valve implantation. For all cases, will be recorded from a TTE report that is completed on post-operative day 1 or 2 and at 1 year.

Study Arms (2)

General

ACTIVE COMPARATOR

Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.

Procedure: General Endotracheal Anesthesia

Sedation

ACTIVE COMPARATOR

Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.

Procedure: Monitored anesthesia care

Interventions

General Endotracheal Anesthesia PROCEDURE

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

General

Monitored anesthesia care PROCEDURE

Participants receive monitored anesthesia care for their procedure.

Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• George Whitener, M.D.

  Medical University of South Carolina - Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 27, 2019
• Study Start: November 22, 2019
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)