Tricuspid RegurgitationTRICARNCT05064514

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

A study testing Transcatheter Tricuspid Valved Stent Graft in people with Tricuspid Regurgitation and Tricuspid Valve Disease, run by Queen Mary University of London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome
What is being tested?: Transcatheter Tricuspid Valved Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Apr 2022to 21 May 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Barts Health NHS Trust
London, England, E1 1BB

Other trials in United Kingdom

About this study

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

Read the 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
Being tested: Transcatheter Tricuspid Valved Stent Graft
Keywords: Heart, Valve, Implantation, Transcatheter, Carcinoid
Medical subject headings: Tricuspid Valve Insufficiency, Serotonin Syndrome, Carcinoid Heart Disease, Carcinoid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcatheter Tricuspid Valved Stent GraftDevice
Also called TRICENTO
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.

Study groups in NCT05064514
Study group	Role	What they receive
Transcatheter Tricuspid Valved Stent Graft intervention	Experimental	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 Receives: Device: Transcatheter Tricuspid Valved Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

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: measured pre intervention and immediately after the intervention

Secondary outcomes (7)

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
Measured: At baseline, 1 month and 6 months
•To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score
•NYHA assessment
Measured: At baseline, and post intervention at 1 month and 6 months
To evaluate the change in peripheral oedema experienced by patients
1. measure of ankle circumference (cm)
2. assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline, and post intervention at 1 month and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 202221 May 2028

First posted1 Oct 2021
Study start6 Apr 2022
Primary completion21 May 2026 (estimated)
Study completion21 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05064514
Sponsor's protocol ID: 262072
Acronym: TRICAR
Status last verified: May 2026
First submitted: 16 Sep 2021
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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