Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement (NCT04107038) | Clinical Trial Compass
CompletedNot Applicable
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
United States170 participantsStarted 2019-11-22
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.