ABT-CIP-10354

About this trial

Last updated 2 years ago

Study ID

ABT-CIP-10354

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started 3 years ago

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral regurgitation ≥ Grade III in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Key Inclusion Criteria:

- Mitral regurgitation ≥ Grade III 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.