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

NCT ID: NCT05064514

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2028-03-31

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.

Conditions

Tricuspid Regurgitation; Tricuspid Valve Disease; Carcinoid Syndrome; Carcinoid Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transcatheter Tricuspid Valved Stent Graft

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TRICENTO

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Baumbach

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Barts Health NHS Trust

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

262072

Identifier Type: -

Identifier Source: org_study_id