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 range18 Years
SexALL
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…
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