Anesthesia Types for TAVR
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two types of anesthesia affect recovery in individuals undergoing Transcatheter Aortic Valve Replacement (TAVR) for aortic valve stenosis, a condition where the heart's aortic valve doesn't open fully. Participants will receive either monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA). The study examines hospital stay length, ICU admission rates, and procedure success. Adults undergoing TAVR for aortic valve stenosis who can safely receive both types of anesthesia may qualify. As an unphased trial, this study allows participants to contribute to valuable research that could enhance anesthesia practices for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these anesthesia methods are safe for TAVR patients?
Research has shown that both General Endotracheal Anesthesia (GETA) and Monitored Anesthesia Care (MAC) are generally safe for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Studies suggest that MAC might offer some advantages over GETA. Specifically, MAC has been linked to a lower risk of death within 30 days and one year after the procedure, and it may also lead to shorter hospital stays.
GETA, a more traditional method, has been used in many procedures and is considered safe. However, some studies indicate that MAC could result in better outcomes for TAVR patients. Both methods are usually well-tolerated, with serious side effects being rare. Prospective trial participants should consult a healthcare provider to determine the best option.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores different anesthesia techniques for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Unlike the traditional use of general endotracheal anesthesia, this trial considers monitored anesthesia care, which may offer a less invasive option with potentially quicker recovery times. By comparing these two methods, researchers hope to find out if monitored anesthesia care can provide similar or better outcomes with fewer side effects, ultimately enhancing patient comfort and safety during TAVR procedures.
What evidence suggests that this trial's anesthesia types could be effective for TAVR?
Research has shown that monitored anesthesia care (MAC), one of the anesthesia options in this trial, can be more beneficial during transcatheter aortic valve replacement (TAVR). Studies have found that patients receiving MAC have a lower risk of dying within 30 days, experience less kidney damage, and have fewer bleeding problems compared to those receiving general endotracheal anesthesia (GETA), the other anesthesia option in this trial. Patients with MAC also tend to spend less time in the hospital and have shorter procedures. Although GETA is commonly used in many surgeries, evidence suggests it may not offer the same benefits for TAVR as MAC does. Overall, MAC appears to lead to better outcomes for TAVR patients.14567
Who Is on the Research Team?
George Whitener, MD
Principal Investigator
Medical University of South Carolina - Department of Anesthesia
Are You a Good Fit for This Trial?
Adults over 18 needing a TAVR for aortic valve stenosis and can receive both general anesthesia (GA) and monitored anesthesia care (MAC). Excluded are those who don't speak English, have BMI >37, difficult airways, pregnant women, unable to consent, allergic or with contraindications to the anesthetics or TEE.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Transcatheter Aortic Valve Replacement (TAVR) with either monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA)
Immediate Post-operative Monitoring
Participants are monitored for ICU admission and procedural mortality
Follow-up
Participants are monitored for safety and effectiveness after treatment, including paravalvular regurgitation assessment
What Are the Treatments Tested in This Trial?
Interventions
- General Endotracheal Anesthesia
- Monitored anesthesia care
General Endotracheal Anesthesia is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Surgical procedures requiring general anesthesia, including TAVR
- Surgical procedures requiring general anesthesia, including TAVR
- Surgical procedures requiring general anesthesia, including TAVR
- Surgical procedures requiring general anesthesia, including TAVR
- Surgical procedures requiring general anesthesia, including TAVR
- Surgical procedures requiring general anesthesia, including TAVR
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor