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Mitral Valve Replacement System

Mitral Valve Replacement for Mitral Valve Regurgitation

N/A

Waitlist Available

Led By Rajendra Makkar, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

Clinically significant, symptomatic mitral regurgitation

High risk for open-heart surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial will test a new mitral valve replacement system to see if it is safe and effective.

Who is the study for?

This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery but meet specific anatomical criteria. It's not suitable for those considered inoperable or with unsuitable anatomy.Check my eligibility

What is being tested?

The study is testing the Edwards EVOQUE Eos Mitral Valve Replacement System to assess its safety and performance as a treatment option for mitral valve regurgitation.See study design

What are the potential side effects?

Potential side effects of the procedure may include bleeding, infection, blood clots, heart rhythm problems, stroke, or device malfunction. Specific side effects will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have serious symptoms from a leaky heart valve.

Select...

I am considered high risk for open-heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 6 months, 12 months, annual for five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 6 months, 12 months, annual for five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 6 months, 12 months, annual for five years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite of major adverse events

Secondary outcome measures

Clinical Success

Device Success

NYHA functional class

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,451 Total Patients Enrolled

Rajendra Makkar, MDPrincipal InvestigatorCedars-Sinai Medical Center, Los Angeles, CA

Media Library

Edwards EVOQUE Eos Mitral Valve Replacement System (Mitral Valve Replacement System) Clinical Trial Eligibility Overview. Trial Name: NCT02718001 — N/A

Mitral Valve Regurgitation Research Study Groups: Treatment

Mitral Valve Regurgitation Clinical Trial 2023: Edwards EVOQUE Eos Mitral Valve Replacement System Highlights & Side Effects. Trial Name: NCT02718001 — N/A

Edwards EVOQUE Eos Mitral Valve Replacement System (Mitral Valve Replacement System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02718001 — N/A

Frequently Asked Questions

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

How many different venues are managing this clinical investigation?

"This trial is being administered across 10 sites, such as the Hospital of the University of Pennsylvania in Philadelphia and Northwestern University in Chicago. Additionally, there are several other clinical locations including The University of Virginia Health System in Charlottesville."

Answered by AI

How many volunteers are being recruited for this research endeavor?

"Affirmative, the registry at clinicaltrials.gov states that enlistment is still open for this research study, which was initially listed on February 1st 2015 and most recently refreshed on September 16th 2022. 123 participants are required to be recruited over 7 locations."

Answered by AI

Is the research team still looking for participants to join this experiment?

"Affirmative. Per information available from clinicaltrials.gov, this medical experiment was first announced on February 1st 2015 and has since been modified as recently as September 16th 2022. 123 participants will be recruited between 7 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Edwards EVOQUE Eos MISCEND Study

2015. "Edwards EVOQUE Eos MISCEND Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02718001.

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