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Recruiting NCT07244939

Cephea South America Feasibility Study

No phase Interventional Mitral Regurgitation Mitral Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cephea Mitral Valve System.
Who it may be relevant to
Registry conditions: Mitral Regurgitation, Mitral Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Interventions

  • Device Cephea Mitral Valve System
    Cephea Mitral Valve System

Primary outcome measures

  • Freedom from all-cause mortality [Time frame: 30 days post implant]
  • Reduction of MR to ≤ Grade I [Time frame: 30 days post implant]

Eligibility criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Chile · 2 centers
  • Instituto Nacional del Torax — Santiago
  • Hospital Clinico San Borja Arriarán — Santiago
Brazil · 1 center
  • Instituto do Coracao (InCor) - HCFMUSP — São Paulo

Identifiers

NCT: NCT07244939 · ABT-CIP-10554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗