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Anesthesia Types for TAVR

N/A

Recruiting

Led By George Whitener, M.D.

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis

Adult patients who are medically eligible to receive both anesthetics (GA and MAC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

Study Summary

This trial is studying the effects of two types of anesthesia on people undergoing a heart valve replacement procedure.

Who is the study for?

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.Check my eligibility

What is being tested?

The study compares two types of anesthesia in patients undergoing TAVR: MAC versus GA. It looks at hospital stay length, ICU admission rates, procedural mortality and if using TEE during GA affects device success.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with anesthesia such as nausea, vomiting, sore throat from intubation under GA; less sedation-related issues like drowsiness or confusion might be expected with MAC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult getting a valve replacement through my thigh for a narrowed heart valve.

Select...

I can safely receive general and monitored anesthesia care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hospital Length of Stay

ICU Admission Rate

Procedural Mortality

Secondary outcome measures

Paravalvular Regurgitation

Trial Design

2Treatment groups

Active Control

Group I: SedationActive Control1 Intervention

Participants randomized to group B will receive monitored anesthesia care as their anesthetic procedure.

Group II: GeneralActive Control1 Intervention

Participants randomized to group A will receive general endotracheal anesthesia as their anesthetic procedure.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,445 Total Patients Enrolled

George Whitener, M.D.Principal Investigator - Medical University of South Carolina - Department of Anesthesia

MUSC Children's Hospital, Medical University of South Carolina

Media Library

General Endotracheal Anesthesia Clinical Trial Eligibility Overview. Trial Name: NCT04107038 — N/A

Transcatheter Aortic Valve Replacement Research Study Groups: Sedation, General

Transcatheter Aortic Valve Replacement Clinical Trial 2023: General Endotracheal Anesthesia Highlights & Side Effects. Trial Name: NCT04107038 — N/A

General Endotracheal Anesthesia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04107038 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new participants to join in this clinical investigation?

"Confirmed, according to data hosted on clinicaltrials.gov this experiment is currently recruiting patients. This study was originally posted on November 22nd 2019 and recently refreshed on February 25th 2022. The researchers require 170 participants from a single site for their investigation."

Answered by AI

How many individuals are enrolled in this research program?

"Affirmative. Documentation on clinicaltrials.gov shows that this medical trial, which was made available to the public on November 22nd 2019, is actively seeking participants. A total of 170 individuals are needed at 1 specified location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

George Whitener 2019. "Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04107038.

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