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Procedure
EmStop System for Aortic Valve Stenosis (CAPTURE-1 Trial)
N/A
Waitlist Available
Research Sponsored by EmStop Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 21 and 90 years of age at the time of consent
Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
Must not have
Requires urgent or emergent TAVR procedure
Hepatic failure (Child-Pugh class C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedural
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a device to protect against embolism during heart procedures. It's being tested on 15 people in the US for safety and performance.
Who is the study for?
This trial is for adults aged 21-90 with aortic valve stenosis, suitable heart anatomy for device placement, and who can undergo MRI. They must not need urgent TAVR, have severe liver or kidney disease, recent stroke/heart attack, bleeding disorders, be pregnant/lactating or in another study.
What is being tested?
The EmStop Embolic Protection System is being tested on patients to see if it's safe and works well during transcatheter aortic valve replacement (TAVR) procedures. The trial will include 15 subjects at two U.S. sites.
What are the potential side effects?
Potential side effects may include reactions to the device material like nickel-titanium allergy, complications from the procedure such as bleeding or vascular injury, and issues related to MRI contraindications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 90 years old.
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I am eligible for a TAVR procedure on my aortic valve using an Abbott or Medtronic valve.
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My ascending aorta is 8 cm or longer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need an urgent heart valve replacement.
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My liver is severely damaged (Child-Pugh class C).
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I have a blood clotting condition that heparin can't manage.
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I have not had a heart attack in the last 30 days.
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My kidney function is very low.
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I have had a stroke or TIA in the last 6 months, or I have lasting effects from a past stroke.
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I do not have an ongoing infection or fever above 38°C with high white blood cell count.
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I am currently receiving treatment to dissolve blood clots.
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I have a history of bleeding disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedural
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedural
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Device procedural success
Secondary study objectives
Average number of captured particles ≥140 μm in diameter
Gross and histologic evaluation of captured embolic debris
Total acute infarct burden
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EmStop Embolic Protection SystemExperimental Treatment1 Intervention
Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).
Find a Location
Who is running the clinical trial?
EmStop IncLead Sponsor
Bright Research PartnersIndustry Sponsor
17 Previous Clinical Trials
2,662 Total Patients Enrolled
Emily VollbrechtStudy DirectorBright Research Partners