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

NCT05064514 | Active Not Recruiting DMC

• 1 other identifier: 262072
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart; Valve; Implantation; Transcatheter; Carcinoid

Outcome Measures

Primary Outcomes (1)

• The number of patients with successful implantation of the TRICENTO bioprosthesis

  with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)

  measured pre intervention and immediately after the intervention

Secondary Outcomes (7)

• To assess the safety of the Tricuspid Valved Stent Graft implantation procedure in patients with carcinoid heart disease with severe symptomatic TR and significant systolic backflow in the hepatic and caval veins, and who are not suitable for surgery.

  At baseline, 1 month and 6 months

• •To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score

  At baseline, and post intervention at 1 month and 6 months

• To evaluate the change in peripheral oedema experienced by patients

  At baseline, 1 month and 6 months

• To evaluate the change in of number of admissions to hospital for heart failure

  6 months before procedure and 6 months post implantation.

• To evaluate the change in patient reported quality of life (EuroQol- 5 Dimension - EQ5D)

  At baseline, and post intervention at 1 month and 6 months

Study Arms (1)

Transcatheter Tricuspid Valved Stent Graft intervention

EXPERIMENTAL

Participants who have carcinoid heart disease with severe symptomatic tricuspid regurgitation and with a significant backflow in the caval and hepatic veins will be treated with the implantation of the Transcatheter Tricuspid Valved Stent Graft

Device: Transcatheter Tricuspid Valved Stent Graft

Interventions

Transcatheter Tricuspid Valved Stent Graft DEVICE

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.

Also known as: TRICENTO

Transcatheter Tricuspid Valved Stent Graft intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age ≥18 yrs
• Carcinoid Heart Disease
• NYHA Class II - IV
• Severe symptomatic tricuspid regurgitation
• Inoperable due to active tumour process or patient declines an operative intervention
• Patient willing and able to consent and comply with specified study evaluations
• Adequate understanding of written or spoken English (to complete validated questionnaires)

You may not qualify if:

• Previous tricuspid valve repair or replacement
• Permanent vena cava filter
• Mega atrium
• Tricuspid valve stenosis
• Thrombosis of lower venous system
• Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
• Active endocarditis
• Subject is on chronic dialysis
• Bleeding disorders or hypercoaguable state
• Hemodynamic instability or on IV inotropes
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically eg contrast
• Contraindication to anticoagulants or antiplatelet medication
• Known allergy to Nitinol (Titanium or Nickel) alloy, gold or porcine tissue
• Untreated clinically significant coronary artery disease requiring revascularization
• Any Percutaneous Coronary Intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure

Sponsors & Collaborators

• Queen Mary University of London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Barts Health NHS Trust

London, England, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Serotonin Syndrome; Carcinoid Heart Disease; Carcinoid Tumor

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Malignant Carcinoid Syndrome; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Andreas Baumbach

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 1, 2021
• Study Start: April 6, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)