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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The number of patients with successful implantation of the TRICENTO bioprosthesis
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
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
Arms & Interventions
Transcatheter Tricuspid Valved Stent Graft intervention
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
Intervention: Transcatheter Tricuspid Valved Stent Graft (Device)
Outcomes
Primary Outcomes
The number of patients with successful implantation of the TRICENTO bioprosthesis
Time Frame: measured pre intervention and immediately after the intervention
with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)
Secondary Outcomes
- •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)
- To evaluate the change in patient reported quality of life (Minnesota Living With Heart Failure - MLFHQ)(At baseline, and post intervention at 1 month and 6 months)
- 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 change in patient reported quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ))(At baseline, and post intervention at 1 month and 6 months)