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Tendyne Valve System for Mitral Annular Calcification
Study Summary
This trial is testing a new mitral valve replacement system for people with severe mitral regurgitation and annular calcification.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a chest condition that prevents certain surgical procedures.Your heart's left ventricle is larger than 7.0 cm when it's full of blood.I have not had a stroke in the last six months.I have blood disorders that cannot be treated effectively.I have not had a heart attack in the last 30 days.I have no planned heart surgery or procedures 30 days before or after the Tendyne procedure.I have severe issues with my heart's right side valves or muscles.I have a heart condition, but it's not due to dilated cardiomyopathy.I am on hemodialysis for advanced kidney disease.I cannot or do not want to take warfarin for 6 months after my valve surgery.Your lung function is very low, less than half of what is expected for someone your age and size.I have a blood clot in my heart's left side.I am allergic or react badly to certain medications used during or after procedures.I have high blood pressure in the arteries of my lungs.My heart condition limits my physical activity but I can still walk.My heart's pumping ability is significantly reduced.I have severe symptoms from mitral valve regurgitation.I need home oxygen or take daily oral steroids for my COPD.You are allergic to nickel or titanium.Your heart's mitral or left ventricular anatomy is not suitable for the Tendyne mitral valve implant.My severe mitral valve narrowing cannot be treated with less invasive procedures.I have heart issues that can be treated with a stent or bypass surgery.I am currently on antibiotics for an infection.My heart condition is deemed too risky for regular surgery, but suitable for a less invasive valve procedure.I refuse to receive blood transfusions.You have had a permanent mitral device (like MitraClip) implanted in the past.I have severe narrowing in my neck arteries causing symptoms.You had a CRT device or IPG implanted within the last three months.I am 18 years old or older.I have health issues not related to my heart that may shorten my life to under a year.I had endocarditis less than 6 months ago.I have not needed strong heart medications or machines to support my heart's pumping in the last month.
- Group 1: Device Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any locales in North America that are executing this clinical trial?
"Currently, this clinical trial is being conducted at 4 sites in Wichita, Morgantown and Minneapolis as well as other locales. If you choose to participate, it would be wise to select the nearest location to avoid extensive travel costs."
Are any more participants being accepted for this clinical experiment?
"As evidenced by the clinicaltrials.gov webpage, this medical study is no longer recruiting participants; its first posting was on October 10th 2018 and it has not been updated since January 8th 2022. However, there are a plethora of other trials currently searching for volunteers to join them."
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