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.
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
- Are there results?
- Not yet: the study is under way
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.
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
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 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 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
- measure of ankle circumference (cm)
- 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.
- 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.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andreas Baumbach, Principal investigator, Queen Mary University of London
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05064514
- Acronym / sponsor ID
- TRICAR / 262072
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome, Carcinoid Heart Disease
- Keywords
- Heart, Valve, Implantation, Transcatheter, Carcinoid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 21 May 2026 (estimated)
- Study completion
- 21 May 2028 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Tricuspid Valved Stent Graft intervention | Experimental | Device: Transcatheter Tricuspid Valved Stent GraftParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Tricuspid Valved Stent GraftAlso: TRICENTOAll 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. | Device | Transcatheter Tricuspid Valved Stent Graft intervention |
Primary outcome
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)
7 secondary outcomes
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.
Time frame: At baseline, 1 month and 6 months
•To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score
Time frame: At baseline, and post intervention at 1 month and 6 months
To evaluate the change in peripheral oedema experienced by patients
Time frame: At baseline, 1 month and 6 months
To evaluate the change in of number of admissions to hospital for heart failure
Time frame: 6 months before procedure and 6 months post implantation.
To evaluate the change in patient reported quality of life (EuroQol- 5 Dimension - EQ5D)
Time frame: 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))
Time frame: 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)
Time frame: At baseline, and post intervention at 1 month and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation
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Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
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Not yet recruitingObservational study
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Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Baumbach principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with successful implantation of the TRICENTO bioprosthesis (time frame: measured pre intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.