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

Study Overview
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Brief Summary
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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.

Detailed Description
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After being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. This will involve a detailed medical history, a CT and an echo scan. Once it is agreed that the participant is suitable for the study, a custom-made TRICENTO valve is prescribed and made. Participants need to be admitted to hospital for the TRICENTO device to be implanted. Before the device is implanted the participant will have further tests and measurements completed eg ECG, a Cardiac MRI, physical measurements such as height, weight and blood pressure, blood tests, questionnaires and measuring how far they can walk in 6 minutes. The device is implanted in a cath lab procedure which should take about 30-60 minutes in total. Participants should be discharged from hospital about 2-3 days later after recovery and further echocardiogram, blood tests and questionnaires. Follow up visits are at 1 month and 6 months after the procedure. The following measurements such as an ECG, echocardiogram, and physical measurements (height, weight and blood pressure), some blood tests, questionnaires and measuring how far they can walk in 6 minutes will be repeated at 1 month and at 6 months after the procedure. A cardiac MRI will also be repeated at 6 months after the procedure. All these tests are to measure whether the TRICENTO valve improves the participant's heart function, symptoms and quality of life.

Official Title
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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

Conditions
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Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome, Carcinoid Heart Disease

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valved Stent Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcatheter Tricuspid Valved Stent Graft intervention<br>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<br>* 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.<br>* Other names: TRICENTO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The number of procedural complications (re-interventions related to the device or access procedure, major vascular or bleeding complication (VARC), cardiac death during hospital stay (max 7 days) Rate of death all causes | At baseline, 1 month and 6 months | 
| •To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score | •NYHA assessment | At baseline, and post intervention at 1 month and 6 months | 
| To evaluate the change in peripheral oedema experienced by patients | measure of ankle circumference (cm) assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4 | At baseline, 1 month and 6 months | 
| To evaluate the change in of number of admissions to hospital for heart failure | Count of number of hospital admissions 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) | Measure EQ5D scores for all patients | At baseline, and post intervention at 1 month and 6 months | 
| To evaluate the change in patient reported quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ)) | Measure Kansas City Cardiomyopathy Questionnaire scores for all patients | At baseline, and post intervention at 1 month and 6 months | 
| To evaluate the change in patient reported quality of life (Minnesota Living With Heart Failure - MLFHQ) | Measure MLFHQ scores for all patients | At baseline, and post intervention at 1 month and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart, Valve, Implantation, Transcatheter, Carcinoid