Clinical trial · Interventional
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
NCT05064514CI-TRIAL-00110820TRICARactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Heart Disease | — | UNRESOLVED | — |
| Carcinoid Syndrome | — | UNRESOLVED | — |
| Tricuspid Regurgitation | — | UNRESOLVED | — |
| Tricuspid Valve Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcatheter Tricuspid Valved Stent Graft | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transcatheter Tricuspid Valved Stent Graft intervention
- description
- 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
- interventionNames
- Device: Transcatheter Tricuspid Valved Stent Graft
Primary outcomes (1)
- measure
- The number of patients with successful implantation of the TRICENTO bioprosthesis
- timeFrame
- measured pre intervention and immediately after the intervention
- description
- with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)
Secondary outcomes (7)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.