Transcatheter Aortic Valve ReplacementNCT04107038
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
A study testing General Endotracheal Anesthesia and Monitored anesthesia care in people with Transcatheter Aortic Valve Replacement, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- General Endotracheal Anesthesia and Monitored anesthesia care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography 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.
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- General Endotracheal Anesthesia, Monitored anesthesia care
- Keywords
- Anesthesia, TAVR, Cardiothoracic, Cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Endotracheal AnesthesiaProcedure or surgery
Participants receive general endotracheal anesthesia for the procedure, as well as analyzing the information from their transesophageal echocardiography per routine clinical care.
Monitored anesthesia careProcedure or surgery
Participants receive monitored anesthesia care for their procedure.
| Study group | Role | What they receive |
|---|---|---|
| General | Active comparator | Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure. Receives: Procedure: General Endotracheal Anesthesia |
| Sedation | Active comparator | Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure. Receives: Procedure: Monitored anesthesia care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
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.
Measured: Up to 1 month
ICU Admission Rate
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.
Measured: Up to 48 hours
Procedural Mortality
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.
Measured: Up to 30 days
Secondary outcomes (1)
Paravalvular Regurgitation
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start22 Nov 2019
- Primary completion15 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Whitener, Medical University of South Carolina
- Investigators
- George Whitener, M.D., Principal investigator, Medical University of South Carolina - Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107038
- Sponsor's protocol ID
- Pro00088473
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT04107038
- Acronym / sponsor ID
- Pro00088473
- Conditions
- Transcatheter Aortic Valve Replacement
- Keywords
- Anesthesia, TAVR, Cardiothoracic, Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General | Active comparator | Procedure: General Endotracheal AnesthesiaParticipants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure. |
| Sedation | Active comparator | Procedure: Monitored anesthesia careParticipants randomized to group B will receive monitored anesthesia care as their anesthetic procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Endotracheal AnesthesiaParticipants receive general endotracheal anesthesia for the procedure, as well as analyzing the information from their transesophageal echocardiography per routine clinical care. | Procedure or surgery | General |
| Monitored anesthesia careParticipants receive monitored anesthesia care for their procedure. | Procedure or surgery | Sedation |
Primary outcome
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.
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Whitener, M.D. principal investigator
Medical University of South Carolina - Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Endotracheal Anesthesia and Monitored anesthesia care in people with Transcatheter Aortic Valve Replacement, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: Up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.