New valve implant offers hope for rare heart condition

NCT ID NCT05064514

Disease control Sponsor: Queen Mary University of London Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a custom-made artificial heart valve, called TRICENTO, in 15 people with carcinoid heart disease who have severe leakage of the tricuspid valve and cannot have surgery. The valve is delivered through a catheter, avoiding open-heart surgery. The goal is to see if it reduces valve leakage and improves symptoms and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TRICENTO valved stent graft (a custom-made artificial heart valve delivered through a catheter)
What this could lead to: If it works, this could offer a less invasive treatment option for people with carcinoid heart disease who have severe valve leakage and cannot undergo open-heart surgery.
What could go wrong: This is a very early, small study with only 15 participants, so results may not apply to everyone. The procedure carries risks like any heart implant, and the valve may not work as intended or could cause complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carcinoid heart disease carcinoid syndrome carcinoid tumor serotonin syndrome tricuspid valve disorder tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoid heart disease Carcinoid syndrome Tricuspid regurgitation Tricuspid valve disease

New valve implant offers hope for rare heart condition

What the study statuses mean