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NCT02397668 · ClinicalTrials.gov registry record · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
A NA study of Tricuspid Valve Disease, sponsored by Corvivo Cardiovascular.
- Recruiting
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT02397668: Recruiting NA study of Tricuspid Valve Disease, sponsored by Corvivo Cardiovascular.
NCT02397668 is a NA study of Tricuspid Valve Disease that is actively recruiting participants, run by Corvivo Cardiovascular. The registered enrollment target is 78 participants, below the 320-participant average among 6 other Tricuspid Valve Disease trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397668, a NA study of Tricuspid Valve Disease, is actively recruiting participants, sponsored by Corvivo Cardiovascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Device Success and No TV device- or TV procedure-related SAE's
Conditions Studied
Interventions
- DEVICE CorMatrix Cor TRICUSPID ECM Valve
Study Locations (4)
Alabama
- Springhill Memorial Hospital - Mobile
Indiana
- St Francis Hospital - Indianapolis
Maryland
- Medstar - Baltimore
Ohio
- Cincinnati Children's Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-12-15 |
| Phase | NA |
What NCT02397668 shows while recruiting
NCT02397668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 320-participant average among 6 other Tricuspid Valve Disease trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Tricuspid Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which CorMatrix Cor TRICUSPID ECM Valve is the first listed.
NCT02397668 reports a single indexed study location in Alabama, Indiana, Maryland.
Frequently Asked Questions
What is clinical trial NCT02397668 about?
NCT02397668 is a clinical study titled "CorMatrix Cor TRICUSPID ECM Valve Replacement Study". 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.
What is the current status of trial NCT02397668?
This trial is currently recruiting. It is a NA study. The enrollment target is 78 participants. The study started on 2022-08-01. Estimated completion is 2026-12-15.
What conditions does trial NCT02397668 study?
This clinical trial studies the following conditions: Tricuspid Valve Disease.
What interventions are being tested in trial NCT02397668?
The interventions under investigation include: CorMatrix Cor TRICUSPID ECM Valve (DEVICE).
Who is sponsoring clinical trial NCT02397668?
This trial is sponsored by Corvivo Cardiovascular, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02397668 being conducted?
This trial has 4 study locations across Alabama, Indiana, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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