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Procedure

EmStop System for Aortic Valve Stenosis (CAPTURE-1 Trial)

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedural

Awards & highlights

CAPTURE-1 Trial 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.Check my eligibility

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.See study design

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.

CAPTURE-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 21 and 90 years old.

Select...

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.

CAPTURE-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedural

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedural

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedural for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Device procedural success

Secondary outcome measures

Average number of captured particles ≥140 μm in diameter

Gross and histologic evaluation of captured embolic debris

Occurrence of Transient Ischemic Attack (TIA)

+1 more

CAPTURE-1 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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

EmStop IncLead Sponsor

Bright Research PartnersIndustry Sponsor

13 Previous Clinical Trials

1,739 Total Patients Enrolled

Emily VollbrechtStudy DirectorBright Research Partners

Frequently Asked Questions

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

Is there a possibility of me joining this clinical experiment?

"This clinical trial is recruiting approximately 15 eligible participants who suffer from aortic valve stenosis and are between 21 to 90 years of age."

Answered by AI

Does this research offer the opportunity for septuagenarians to participate?

"Prospective participants must meet the age requirements set forth by this medical study, which state that enrollees should be between 21 and 90 years old."

Answered by AI

Are there any openings currently available for participants in this clinical trial?

"Unfortunately, the clinical trial hosted online is not presently taking patients. Despite being initially posted on December 1st 2023 and last updated on October 24th of that same year, recruitment for this study has already closed. However, there are a plethora of other medical studies actively searching for participants right now - 170 in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Controlled Arterial Protection to Ultimately Remove Embolic Material

2023. "Controlled Arterial Protection to Ultimately Remove Embolic Material". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06103591.

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