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RECRUITING NA

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

NCT06137807 · View on ClinicalTrials.gov ↗

Study Summary

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Interventions

  • DEVICE TricValve® Transcatheter Bicaval Valve System

Study Locations (20)

Florida

  • Delray Medical Center — Delray Beach
  • Largo Medical Center — Largo
  • Tampa General Hospital — Tampa

Massachusetts

  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • Lahey Hospital & Medical Center — Burlington

Arizona

  • St. Joseph's Hospital and Medical Center — Phoenix
  • Tucson Medical Center — Tucson

California

  • Scripps Memorial Hospital La Jolla — San Diego
  • UCSF — San Francisco

Illinois

  • Endeavor Health, Glenbrook Hospital — Glenview
  • Chicago Advocate Christ — Palos Park

Missouri

  • Saint Luke's Mid America Heart Institute — Kansas City
  • Washington University St Louis — St Louis

New York

  • North Shore University Hospital — Manhasset
  • Montefiore Medical Center — The Bronx

Indiana

  • Ascension Medical Group St. Vincent The Heart Center of Indiana — Indianapolis

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-07-23
Est. Completion 2029-09
Phase NA

Sponsor

P+F Products + Features USA

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06137807

The ClinicalTrials.gov registry entry for NCT06137807 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is P+F Products + Features USA, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which TricValve® Transcatheter Bicaval Valve System 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: NCT06137807 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Massachusetts, Arizona. 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 NCT06137807 about?

NCT06137807 is a clinical study titled "TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)". The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcat...

What is the current status of trial NCT06137807?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-07-23. Estimated completion is 2029-09.

What conditions does trial NCT06137807 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation, 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 NCT06137807?

The interventions under investigation include: TricValve® Transcatheter Bicaval Valve System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06137807?

This trial is sponsored by P+F Products + Features USA, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06137807 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. 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