NCT05064514Active, not recruiting
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
Single Centre, Prospective, Single Arm Open Label Series of a Transcatheter Tricuspid Valved Stent Graft System for the Reduction of Tricuspid Regurgitation and Improved Patient Reported Outcomes in Patients With Carcinoid Heart Disease
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 16 Sept 2021
- Start date
- Apr 2022
- Primary completion date
- May 2026
- Lead sponsor
- Queen Mary University of London
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT05064514
What you commit to
- Study type: Interventional
- Planned participants: 15
- From Apr 2022 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- General Inclusion Criteria
- 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)
- General Exclusion Criteria
- 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
- Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- Contraindication to long-term anticoagulation
- Life expectancy according to tumour development is less than 12 months
- Impaired judgment and/or is undergoing emergency treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.