CorMatrix Cor TRICUSPID ECM Valve Replacement Study
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ClinicalTrials.gov Identifier: NCT02397668 |
Recruitment Status :
Recruiting
First Posted : March 25, 2015
Last Update Posted : August 20, 2020
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Tracking Information | |||||||||
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First Submitted Date ICMJE | March 6, 2015 | ||||||||
First Posted Date ICMJE | March 25, 2015 | ||||||||
Last Update Posted Date | August 20, 2020 | ||||||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Procedural Success [ Time Frame: 30 days postop ] Device Success and No TV device- or TV procedure-related SAE's
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Original Primary Outcome Measures ICMJE |
Procedural Success as measured by: Device success and No TV device- or TV procedure-related SAE's [ Time Frame: 30 day ] | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | CorMatrix Cor TRICUSPID ECM Valve Replacement Study | ||||||||
Official Title ICMJE | CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility | ||||||||
Brief Summary | To demonstrate the proof of principle and initial clinical safety of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve) and increase the efficiency of the device development process by identifying appropriate modifications to the implant procedure or the device. | ||||||||
Detailed Description | CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Early Feasibility Study is proposed to obtain initial insights into the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 8 sites. Up to 15 subjects will undergo tricuspid valve replacement (TVR) with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease. The cohort will include up to 10 adult patients and up to 5 pediatric patients. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Multi-center, prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Tricuspid Valve Disease | ||||||||
Intervention ICMJE | Device: CorMatrix Cor TRICUSPID ECM Valve
CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.
Other Name: Cor PEDIATRIC Tricuspid ECM Valve
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Study Arms ICMJE | 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 10 adults subjects and up to 5 pediatric subjects.
Intervention: Device: CorMatrix Cor TRICUSPID ECM Valve
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
15 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2024 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 70 Years (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT02397668 | ||||||||
Other Study ID Numbers ICMJE | 14-PR-1101 Rev. G | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | CorMatrix Cardiovascular, Inc. | ||||||||
Study Sponsor ICMJE | CorMatrix Cardiovascular, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | CorMatrix Cardiovascular, Inc. | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |