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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 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.

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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

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

FieldValue
Enrollment Target 92 participants
Start Date 2022-08-10
Est. Completion 2026-12
Phase NA

Sponsor

Corvivo Cardiovascular

2 total trials

What the Registry Record Tells You About NCT05742906

The ClinicalTrials.gov registry entry for NCT05742906 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 318-participant average among 6 other Tricuspid Valve Disease trials with a reported enrollment target (71% lower). The listed sponsor is Corvivo Cardiovascular, which has 2 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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