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Evaluating a new valve system for treating severe mitral regurgitation

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

NA · Abbott Medical Devices · NCT03433274

This study is testing a new valve system to see if it can help people with severe mitral regurgitation feel better and improve their heart health.

Quick facts

PhaseNA
Study typeInterventional
Enrollment958 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices (industry)
Locations80 sites (Birmingham, Alabama and 79 other locations)
Trial IDNCT03433274 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System in patients with symptomatic moderate-to-severe or severe mitral regurgitation, as well as those with severe mitral annular calcification. The study involves a randomized controlled design with four cohorts, including a comparison to the MitraClip system. Participants will be assessed for their eligibility based on specific criteria related to their heart condition and overall health. The trial aims to provide insights into the potential benefits of this innovative valve system for patients with significant mitral valve disease.

Who should consider this trial

Good fit: Ideal candidates include individuals with symptomatic moderate-to-severe or severe mitral regurgitation or severe mitral annular calcification who meet specific health criteria.

Not a fit: Patients with severe tricuspid regurgitation, significant left ventricular dysfunction, or those who have had prior surgical interventions on the mitral valve may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could offer a new treatment option for patients suffering from severe mitral regurgitation, potentially improving their quality of life and heart function.

How similar studies have performed: Other studies have shown promise with similar transcatheter valve approaches, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
* NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
* The local site heart team determines that the subject has been adequately treated per applicable standards
* Not a member of a vulnerable population

Exclusion Criteria:

* Mitral valvular vegetation or mass
* Left ventricular ejection fraction \< 25%
* Left ventricular end diastolic diameter \> 7.0 cm
* Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
* Aortic valve disease requiring surgery or transcatheter intervention
* Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
* Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
* Subject undergoing hemodialysis due to chronic renal failure
* Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
* Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Where this trial is running

Birmingham, Alabama and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease, Heart, Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.