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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-index procedure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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A team of heart specialists has decided I can't have standard heart surgery.
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My heart condition affects my daily life even with treatment.

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

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

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
635 Previous Clinical Trials
405,044 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

Frequently Asked Questions

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

Is there an opportunity for participants to join this experiment?

"Clinicaltrials.gov states this medical study is no longer actively seeking participants, as it was first posted on November 1st 2014 and last edited on July 26th 2022. However, 98 other trials are currently recruiting patients."

Answered by AI

How many research centers are currently conducting this trial?

"Emory University Hospital in Atlanta, West virginia University in Morgantown, and Pinnacle Health - Harrisburg Hospital in Harrisburg are all sites currently recruiting patients for this clinical trial. An additional 7 locations have been identified as possible enrolment spots."

Answered by AI
~18 spots leftby Mar 2025