EmStop Embolic Protection for Aortic Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two devices to determine which one better captures and removes debris during a heart valve replacement procedure called TAVR. It targets individuals with aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. Participants should already plan to undergo the TAVR procedure and have a left ventricular ejection fraction of at least 30%, indicating adequate heart function. The trial seeks to identify which device, including the EmStop Embolic Protection System, offers superior protection against complications. As an unphased trial, it provides participants the chance to contribute to research that could enhance future heart valve replacement procedures.
What prior data suggests that the EmStop Embolic Protection System is safe for use during TAVR procedures?
Research has shown that the EmStop Embolic Protection System is generally safe for patients undergoing heart valve replacement procedures. In a recent study, patients using the EmStop system demonstrated good safety outcomes. Researchers monitored them for 30 days post-procedure to ensure no serious safety issues arose. These findings suggest that the device effectively captures and removes debris during heart procedures.
The Boston Scientific Sentinel device, already approved and used in similar procedures, has a known safety record, though any device carries some risks. Overall, both devices in this trial have shown positive safety results in previous studies, offering reassurance about their use in heart procedures.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the EmStop Embolic Protection System for aortic stenosis because it offers a potentially safer and more effective way to prevent embolic events during heart valve procedures. Unlike current solutions, such as the Boston Scientific Sentinel device, which is the standard of care, EmStop might offer improved embolic protection by utilizing a novel mechanism or design that enhances particle capture from the bloodstream. This innovation could lead to fewer complications and better outcomes for patients undergoing transcatheter aortic valve replacement (TAVR).
What evidence suggests that this trial's devices could be effective for aortic stenosis?
This trial will compare the EmStop Embolic Protection System with the Boston Scientific Sentinel device. Research shows that the EmStop Embolic Protection System catches and removes clots or debris during heart valve replacement surgeries. Early results from studies, such as the CAPTURE-1 trial, indicated that the EmStop system effectively captures this debris, helping to prevent strokes during the procedure. Although still under study, the system aims to provide a straightforward and effective way to protect the brain from debris. The Boston Scientific Sentinel device, used for comparison in this trial, has already demonstrated high success rates, capturing debris in over 99% of cases. Both devices aim to lower the risk of complications during heart procedures by catching debris before it can cause harm.12346
Who Is on the Research Team?
Stanley J Chetcuti, MD
Principal Investigator
University of Michigan Health
Are You a Good Fit for This Trial?
This trial is for adults aged 22 or older who need a self-expanding transcatheter aortic valve replacement (TAVR) and have enough heart function. Participants must be able to give consent, follow study procedures, and meet certain heart and blood vessel size requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the TAVR procedure with either the EmStop Embolic Protection System or the Sentinel device
Follow-up
Participants are monitored for safety and effectiveness, including debris capture and non-inferiority endpoints
What Are the Treatments Tested in This Trial?
Interventions
- Boston Scientific Sentinel
- EmStop Embolic Protection System
Trial Overview
The study compares two devices—the EmStop Embolic Protection System and the Boston Scientific Sentinel—to see how well they capture and remove debris during TAVR procedures in patients with aortic valve disease.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
EmStop Inc
Lead Sponsor
Bright Research Partners
Industry Sponsor
Citations
Controlled Arterial Protection to Ultimately Remove ...
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as ...
2.
citoday.com
citoday.com/news/emstop-completes-capture-1-early-feasibility-trial-of-embolic-protection-system-for-tavrEmStop Completes CAPTURE-1 Early Feasibility Trial of ...
The CAPTURE-1 study was designed to assess the safety and performance of the investigational EmStop EPS to capture and remove thrombus during TAVR.
Embolic Protection Devices in Transcatheter Aortic Valve ...
Studies have demonstrated that the Sentinel device is highly effective in capturing embolic debris, with successful capture reported in over 99% ...
4.
ctv.veeva.com
ctv.veeva.com/study/capture-2-controlled-arterial-protection-to-ultimately-remove-embolic-materialCAPTURE-2: Controlled Arterial Protection to Ultimately ...
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture ...
TAVI Archives
CAPTURE-1 study of EmStop embolic protection system concludes. 21st November 2024. EmStop has announced the completion of the CAPTURE-1 early feasibility ...
6.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06103591/controlled-arterial-protection-to-ultimately-remove-embolic-materialControlled Arterial Protection to Ultimately Remove ...
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System ...
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