Cephea South America Feasibility Study | NCT07244939

Studies
Cephea South America Feasibility Study

NCT07244939

Sponsor

Abbott Medical Devices

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Mitral Regurgitation
Mitral Stenosis

Interventions

Cephea Mitral Valve System

Countries

Brazil
Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cephea TMVR	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cephea Mitral Valve System	Device	Cephea Mitral Valve System	Cephea TMVR

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leslie Centeno	Contact	+1 818-294-3041		leslie.centeno@abbott.com
Clinical Project Manager	Contact			Cephea_FS@abbott.com

Overall Officials

Name	Affiliation	Role
Barathi Sethuraman	Abbott Structural Heart	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Coracao (InCor) - HCFMUSP	Recruiting	São Paulo		05403-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency
D008946	Mitral Valve Stenosis

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided