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Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease

NCT05064514 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this investigation is to see if the TRICENTO Valved Stent Graft implant reduces tricuspid regurgitation (TR) and improves the symptoms and quality of life in 15 participants with carcinoid heart disease, and who are not able to have a new valve via a surgical procedure.

Conditions

  • Tricuspid Regurgitation
  • Tricuspid Valve Disease
  • Carcinoid Syndrome
  • Carcinoid Heart Disease

Interventions

DEVICE

Transcatheter Tricuspid Valved Stent Graft

All participants meeting the inclusion and none of the exclusion criteria will be enrolled. A custom-made Transcatheter Tricuspid Valved Stent Graft based on CT to define anatomic dimensions will be made. The system consists of a custom-made valved stent graft delivery system, a custom-made valved stent graft bioprosthesis and a loading system. The bioprosthesis is self-expanding and consists of a stent graft spanning from the inferior vena cava to the superior vena cava and a lateral bicuspid valve element made of thin porcine pericardial leaflets requiring a low closing pressure, and Nitinol support structures. The participants will undergo a minimally invasive, catheter-based procedure to implant the bioprosthesis which is delivered through a 24 French delivery system via transfemoral access. The device can be repositioned and is retrievable.

Sponsors & Collaborators

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Andreas Baumbach · Queen Mary University of London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2026-05-21
Completion
2028-05-21

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064514 on ClinicalTrials.gov