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

Tricuspid Regurgitation Clinical Trial

— TRICAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05064514
• Other study ID #: 262072
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: March 2026

Study information

• Verified date: January 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 2026
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Heart Disease
• Carcinoid Syndrome
• Carcinoid Tumor
• Heart Diseases
• Malignant Carcinoid Syndrome
• Serotonin Syndrome
• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter Tricuspid Valved Stent Graft
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.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London	England

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	•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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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