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

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107038
• Other study ID #: Pro00088473
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: George Whitener, M.D.
• Phone: 843-876-0758
• Email: whiteneg[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Intervention

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.
• Monitored anesthesia care
Participants receive monitored anesthesia care for their procedure.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Paravalvular Regurgitation	Paravalvular regurgitation is a specific type of aortic regurgitation that is determined qualitatively by the echocardiographer. It is defined as the grade of aortic valve regurgitation around the perimeter of the implanted prosthesis. The assigned grade will be classified according to a unifying five-class scheme, at the determination of the cardiologist. Grade of aortic regurgitation is measured as none, mild, moderate, or severe. None is best, severe is worst. For GETA cases, paravalvular regurgitation will be recorded after valve implantation by the anesthesiologist performing TEE, as is routine. For all cases, paravalvular regurgitation will be recorded from a TTE report that is completed on post-operative day 1 or 2 (the 1st post-operative TTE) during routine clinical care, and again by TTE report at 1 year during routine clinical follow-up.	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.