Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Di… (NCT05064514) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
United Kingdom15 participantsStarted 2022-04-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 femal…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients with successful implantation of the TRICENTO bioprosthesis
Timeframe: measured pre intervention and immediately after the intervention