Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
NCT ID: NCT04107038
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2019-11-22
2025-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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General
Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic 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.
Sedation
Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.
Monitored anesthesia care
Participants receive monitored anesthesia care for their procedure.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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George Whitener
Principal Investigator
Principal Investigators
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George Whitener, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina - Department of Anesthesia
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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Pro00088473
Identifier Type: -
Identifier Source: org_study_id
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