Cephea South America Feasibility Study

February 5, 2026 updated by: Abbott Medical Devices
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Recruiting
        • Instituto do Coracao (InCor) - HCFMUSP
        • Principal Investigator:
          • Alexandre Abizaid
        • Contact:
  • Chile
      • Santiago, Chile, 8360160
        • Recruiting
        • Hospital Clinico San Borja Arriaran
        • Contact:
        • Principal Investigator:
          • Gabriel Maluenda
      • Santiago, Chile, 8320000
        • Recruiting
        • Instituto Nacional del tórax
        • Contact:
        • Principal Investigator:
          • Jorge Sandoval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cephea TMVR
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Device: Cephea Mitral Valve System
Cephea Mitral Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from all-cause mortality
Time Frame: 30 days post implant
Primary Safety Endpoint
30 days post implant
Reduction of MR to ≤ Grade I
Time Frame: 30 days post implant
Primary Effectiveness Endpoint
30 days post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Barathi Sethuraman, Abbott Structural Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10554

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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