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

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement
• Interventions: Procedure: General Endotracheal Anesthesia; Procedure: Monitored anesthesia care

• Registration Number: NCT04107038
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2019-11-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General	General Endotracheal Anesthesia	Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.
Sedation	Monitored anesthesia care	Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.

Primary Outcome Measures

Name	Time	Method
ICU Admission Rate	Up to 48 hours	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.
Hospital Length of Stay	Up to 1 month	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.
Procedural Mortality	Up to 30 days	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States