Cephea Early Feasibility Study

Launched by ABBOTT MEDICAL DEVICES · Sep 20, 2021

Keywords

ClinConnect Summary

The Cephea Early Feasibility Study is looking into a new treatment option for patients with mitral valve disease, particularly those experiencing significant symptoms from conditions like mitral regurgitation or mitral stenosis. This study aims to assess how safe and effective the Cephea Mitral Valve System is for these patients, especially for those who are not suitable candidates for traditional open-heart surgery. The trial is currently recruiting participants aged 65 to 74, and it is open to all genders.

To be eligible for this study, participants must have severe mitral valve issues that cause significant symptoms and meet certain heart function criteria. Specifically, they should have a certain level of heart pumping ability and should not have had previous heart surgeries that could interfere with the new valve. Those who join the study can expect to receive the Cephea valve system through a less invasive procedure rather than open-heart surgery, which generally means a quicker recovery time. It’s important to note that this study is still in its early stages, so researchers are gathering valuable information to understand how well this new approach works.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) 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.