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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post implant
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My heart condition is deemed too risky for regular surgery, but suitable for a less invasive valve procedure.
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I am 18 years old or older.

Timeline

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

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device ArmExperimental Treatment1 Intervention
All subjects will undergo procedure with the Tendyne Mitral Valve System.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
405,224 Total Patients Enrolled
Paul Sorajja, MDPrincipal InvestigatorMinneapolis Heart Institute - Abbott Northwestern Hospital
3 Previous Clinical Trials
2,161 Total Patients Enrolled
Kartik Sundareswaran, PhDStudy DirectorAbbott Structural Heart
5 Previous Clinical Trials
4,322 Total Patients Enrolled

Media Library

Tendyne Mitral Valve System (Valve Replacement Device) Clinical Trial Eligibility Overview. Trial Name: NCT03539458 — N/A
Mitral Annular Calcification Research Study Groups: Device Arm
Mitral Annular Calcification Clinical Trial 2023: Tendyne Mitral Valve System Highlights & Side Effects. Trial Name: NCT03539458 — N/A
Tendyne Mitral Valve System (Valve Replacement Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539458 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI
~2 spots leftby Mar 2025