Status:
COMPLETED
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
Lead Sponsor:
Medical University of South Carolina
Conditions:
Transcatheter Aortic Valve Replacement
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04107038
Start Date
November 22 2019
End Date
August 15 2025
Last Update
September 16 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425