CorMatrix Cor TRICUSPID ECM Valve Replacement Study

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Corvivo Cardiovascular, Inc.
Study ID
NCT02397668
Status
Recruiting
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Conditions

  • Tricuspid Valve Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 85 Years
Healthy Volunteers
Accepted

Interventions

  • CorMatrix Cor TRICUSPID ECM Valve — DEVICE
    CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.

Study Details

The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

Key Dates

Start date
Aug 1, 2022
Status verified
Aug 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CorMatrix Cor TRICUSPID ECM Valve
    Tricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects.

Primary Outcome Measure

Procedural Success [ Time Frame: 30 days postop ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Springhill Memorial HospitalMobileAlabama36607
William C Johnson, MD (PRINCIPAL_INVESTIGATOR)
St Francis HospitalIndianapolisIndiana46237
Marc Gerdisch, MD (PRINCIPAL_INVESTIGATOR)
MedstarBaltimoreMaryland21244
Brian Bethea, MD
Cincinnati Children's HospitalCincinnatiOhio45229
David Morales, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mobile, AL

By research site
Springhill Memorial Hospital· Mobile, ALSt Francis Hospital· Indianapolis, INMedstar· Baltimore, MDCincinnati Children's Hospital· Cincinnati, OH

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