| NCT ID | NCT07244939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-17 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Barathi Sethuraman
STUDY DIRECTOR
Abbott Structural Heart
Frequently Asked Questions
Who can join the NCT07244939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07244939 currently recruiting?
Yes, NCT07244939 is actively recruiting participants. Contact the research team at leslie.centeno@abbott.com for enrollment information.
Where is the NCT07244939 trial being conducted?
This trial is being conducted at São Paulo, Brazil, Santiago, Chile, Santiago, Chile.
Who is sponsoring the NCT07244939 clinical trial?
NCT07244939 is sponsored by Abbott Medical Devices. The principal investigator is Barathi Sethuraman at Abbott Structural Heart. The trial plans to enroll 20 participants.