Evaluating a new mitral valve system for patients with severe mitral valve disease

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 aims to assess the preliminary safety and effectiveness of the Cephea Mitral Valve System in treating symptomatic patients with mitral valve disease, specifically those with significant mitral regurgitation or severe mitral stenosis. The approach focuses on patients for whom transcatheter therapy is considered more suitable than traditional open heart surgery. Participants will be evaluated based on specific echocardiographic criteria and left ventricular ejection fraction. The study is designed to gather initial data on the device's performance in a clinical setting.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria.
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Key Exclusion Criteria:

* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
* Need for emergent or urgent surgery.

Where it's running

• Banner-University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California - Davis Medical Center
  Sacramento, California, United States Recruiting
• Los Robles Regional Medical Center
  Thousand Oaks, California, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Leslie Centeno
• Email: leslie.centeno@abbott.com
• Phone: +1 818-294-3041

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

  This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.

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• Outcomes after new edge-to-edge mitral valve repair

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• Surgical implantation of a polymer prosthetic mitral or aortic valve

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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.

  Recruiting Sierra Valve LLC · Thousand Oaks, California · NCT07086534

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.