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Valve Replacement Device

Tendyne Valve System for Mitral Annular Calcification

N/A

Waitlist Available

Led By Paul Sorajja, MD

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

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

Must have

NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)

Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR

Must not have

Chest condition that prevents transapical access

Severe tricuspid regurgitation or severe right ventricular dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new mitral valve replacement system for people with severe mitral regurgitation and annular calcification.

Who is the study for?

This trial is for adults with severe mitral regurgitation and heavy calcification of the mitral valve who are symptomatic, have a heart function classification of at least II, and aren't good candidates for traditional surgery. Excluded are those with other serious heart conditions, pulmonary hypertension, blood disorders untreated by medication, life expectancy under 12 months due to non-cardiac issues, recent heart attacks or strokes, certain lung problems including COPD on oxygen therapy or chronic steroid use, severe kidney disease requiring dialysis, chest conditions preventing access through the ribcage for the procedure.

What is being tested?

The Tendyne Mitral Valve System is being tested in this study. It's a new device implanted via a minimally invasive procedure aimed at replacing the diseased mitral valve without needing open-heart surgery. Participants will be monitored to see how well it works and its safety in patients with significant calcification around their mitral valves.

What are the potential side effects?

Potential side effects may include risks associated with heart procedures such as bleeding or infection; reactions to materials in the device like nickel or titanium if allergic; complications from medications used during/after implantation; possible need for long-term anticoagulation therapy which carries its own risks.

Eligibility Criteria

Inclusion Criteria

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

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My heart condition limits my physical activity but I can still walk.

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I have severe symptoms from mitral valve regurgitation.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chest condition that prevents certain surgical procedures.

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I have severe issues with my heart's right side valves or muscles.

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I have a heart condition, but it's not due to dilated cardiomyopathy.

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I am on hemodialysis for advanced kidney disease.

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I cannot or do not want to take warfarin for 6 months after my valve surgery.

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I have a blood clot in my heart's left side.

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My heart's pumping ability is significantly reduced.

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I am allergic or react badly to certain medications used during or after procedures.

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I have high blood pressure in the arteries of my lungs.

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I need home oxygen or take daily oral steroids for my COPD.

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My severe mitral valve narrowing cannot be treated with less invasive procedures.

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I have heart issues that can be treated with a stent or bypass surgery.

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I am currently on antibiotics for an infection.

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I refuse to receive blood transfusions.

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I have severe narrowing in my neck arteries causing symptoms.

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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 have not needed strong heart medications or machines to support my heart's pumping in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)