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RECRUITING NA

CorMatrix Cor TRICUSPID ECM Valve Replacement Study

NCT02397668 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 78 participants
Start Date 2022-08-01
Est. Completion 2026-12-15
Phase NA

Sponsor

Corvivo Cardiovascular

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02397668

The ClinicalTrials.gov registry entry for NCT02397668 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corvivo Cardiovascular, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02397668 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Alabama, Indiana, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02397668?

The interventions under investigation include: CorMatrix Cor TRICUSPID ECM Valve (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02397668?

This trial is sponsored by Corvivo Cardiovascular, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial