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NCT05742906 · ClinicalTrials.gov registry record · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
A NA study of Tricuspid Valve Disease and Tricuspid Valve Insufficiency, sponsored by Corvivo Cardiovascular.
- Recruiting
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 2
- Study locations
NCT05742906: Recruiting NA study of Tricuspid Valve Disease and Tricuspid Valve Insufficiency, sponsored by Corvivo Cardiovascular.
NCT05742906 is a NA study of Tricuspid Valve Disease and Tricuspid Valve Insufficiency that is actively recruiting participants, run by Corvivo Cardiovascular. The registered enrollment target is 92 participants, below the 318-participant average among 6 other Tricuspid Valve Disease trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05742906, a NA study of Tricuspid Valve Disease and Tricuspid Valve Insufficiency, is actively recruiting participants, sponsored by Corvivo Cardiovascular.
- RECRUITING
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are: * whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months Participants will undergo: * preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years
Primary Outcome
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
Conditions Studied
Interventions
- DEVICE Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
Study Locations (2)
Indiana
- St Francis Hospital - Indianapolis
New York
- Columbia University Irving Medical Center/New York Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT05742906 shows while recruiting
NCT05742906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 318-participant average among 6 other Tricuspid Valve Disease trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Tricuspid Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which Tricuspid valve replacement with the Cor TRICUSPID ECM Valve is the first listed.
NCT05742906 reports a single indexed study location in Indiana, New York.
Frequently Asked Questions
What is clinical trial NCT05742906 about?
NCT05742906 is a clinical study titled "CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study". The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aim...
What is the current status of trial NCT05742906?
This trial is currently recruiting. It is a NA study. The enrollment target is 92 participants. The study started on 2022-08-10. Estimated completion is 2026-12.
What conditions does trial NCT05742906 study?
This clinical trial studies the following conditions: Tricuspid Valve Disease, Tricuspid Valve Insufficiency.
What interventions are being tested in trial NCT05742906?
The interventions under investigation include: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve (DEVICE).
Who is sponsoring clinical trial NCT05742906?
This trial is sponsored by Corvivo Cardiovascular, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05742906 being conducted?
This trial has 2 study locations across Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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