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Prosthetic Valve

Tendyne Mitral Valve System for Mitral Regurgitation

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Severe mitral regurgitation of primary or secondary etiology according to MVARC (Mitral Valve Academic Research Consortium) 2015 defined as: For Degenerative MR: EROA ≥ 40 mm^2 or regurgitant volume ≥ 60ml, For Secondary MR: EROA ≥ 20 mm^2 or regurgitant volume ≥ 30ml
Must not have
Left Ventricle (LV) or Left Atrium (LA) thrombus
Patient has a chest condition that prevents transapical access
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-index procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new mitral valve to see if it is safe and effective for people with severe mitral regurgitation who are not able to have surgery. Follow up evaluations will be done for 5 years.

Who is the study for?
This trial is for adults with severe mitral valve regurgitation who are at least NYHA Class II and not suitable for traditional surgery. Candidates should not have conditions like severe heart calcification, recent heart attacks, or life expectancy less than a year due to other diseases.
What is being tested?
The Tendyne Mitral Valve System is being tested to see if it's safe and works well in treating severe mitral regurgitation in patients who can't undergo standard surgical treatments. Participants will be monitored for five years after the device implantation.
What are the potential side effects?
Potential side effects may include complications related to the heart or blood vessels, reactions to materials in the device (nickel, titanium), infection risks from the procedure, and issues arising from long-term use of anti-coagulation medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have severe leakage in my heart's mitral valve.
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My heart condition affects my daily life even with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a blood clot in my heart's left side.
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I have a chest condition that prevents certain medical procedures.
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I have severe narrowing in my neck arteries causing symptoms.
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I need drugs or devices to help my heart pump during my planned procedure.
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I have no surgeries planned 30 days before or after the implant procedure.
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I am currently on antibiotics for an infection.
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I am not allergic to contrast dyes, blood thinners, nickel, or titanium.
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I am unable or unwilling to give consent for treatment.
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I have high blood pressure in the arteries of my lungs.
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I am on hemodialysis for chronic kidney failure.
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I have severe heart valve issues.
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I have severe heart artery blockages that haven't been treated with stents or surgery.
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I have COPD and use oxygen at home.
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I have health issues not related to my heart that may shorten my life to under a year.
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I refuse to receive blood transfusions.
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I have a heart condition, but it's not due to dilated cardiomyopathy.
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I have blood disorders that cannot be treated effectively.
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I am unable or unwilling to follow the study's required tests and visits.
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I have severe issues with my heart's tricuspid valve or right ventricle.
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I have had surgery or a procedure on my heart valves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-index procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Magnetic Resonance Imaging
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)

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: Tendyne Mitral Valve SystemExperimental Treatment1 Intervention
Patients will undergo transcatheter mitral valve replacement

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
416,152 Total Patients Enrolled

Media Library

Tendyne Mitral Valve System (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02321514 — N/A
Mitral Valve Regurgitation Research Study Groups: Tendyne Mitral Valve System
Mitral Valve Regurgitation Clinical Trial 2023: Tendyne Mitral Valve System Highlights & Side Effects. Trial Name: NCT02321514 — N/A
Tendyne Mitral Valve System (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02321514 — N/A
~17 spots leftby Nov 2025
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