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Completed

NCT Number: NCT04107038

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

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.

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Key information

Conditions

Transcatheter Aortic Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Monitored anesthesia care

Procedure

Participants receive monitored anesthesia care for their procedure.

Primary outcomes

  1. Hospital Length of Stay

    Time frame: 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.

  2. ICU Admission Rate

    Time frame: 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.

  3. Procedural Mortality

    Time frame: 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 outcomes

  1. Paravalvular Regurgitation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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