Transcatheter Mitral Valve Replacement for Severe Mitral Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the feasibility, safety, and performance of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment. It is a single-arm, prospective, multicenter, non-randomized, and open-label study. The investigational device includes a self-expanding mitral bioprosthesis and a sub-annular implant designed to stabilize the valve position. Patients will be assessed for eligibility based on specific anatomical and medical criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Severe mitral regurgitation
* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
* Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
* Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
* Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
* Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Main Exclusion Criteria:

* Mitral stenosis
* Rheumatic valve disease
* Severe calcifications of the mitral annulus and/or mitral leaflets
* Prior surgical or interventional treatment of the mitral valve
* Unsuitable anatomy for the transapical access
* Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
* Untreated clinically significant coronary artery disease requiring revascularization
* LVEF \< 30%
* LVEDD \> 70mm
* Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

Where it's running

• Tucson Medical Center
  Tucson, Arizona, United States Recruiting
• Los Robles Regional Medical Center
  Los Angeles, California, United States Recruiting
• Piedmont Heart
  Atlanta, Georgia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Minneapolis Heart
  Minneapolis, Minnesota, United States Recruiting
• Montefiore Medical Center
  New York, New York, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

  This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.