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

Not Applicable

Active, not recruiting

• Conditions: Tricuspid Valve Disease; Carcinoid Syndrome; Carcinoid Heart Disease; Tricuspid Regurgitation
• Interventions: Device: Transcatheter Tricuspid Valved Stent Graft

• Registration Number: NCT05064514
• Lead Sponsor: Queen Mary University of London

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-01
• Study Start: 2022-04-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-10
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Tricuspid Valved Stent Graft intervention	Transcatheter Tricuspid Valved Stent Graft	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

Primary Outcome Measures

Name	Time	Method
The number of patients with successful implantation of the TRICENTO bioprosthesis	measured pre intervention and immediately after the intervention	with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)

Secondary Outcome Measures

Name	Time	Method
•To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score	At baseline, and post intervention at 1 month and 6 months	•NYHA assessment
To evaluate the change in peripheral oedema experienced by patients	At baseline, 1 month and 6 months	1. measure of ankle circumference (cm); 2. assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4
To evaluate the change in of number of admissions to hospital for heart failure	6 months before procedure and 6 months post implantation.	Count of number of hospital admissions for heart failure
To evaluate the change in patient reported quality of life (EuroQol- 5 Dimension - EQ5D)	At baseline, and post intervention at 1 month and 6 months	Measure EQ5D scores for all patients
To evaluate the change in patient reported quality of life (Minnesota Living With Heart Failure - MLFHQ)	At baseline, and post intervention at 1 month and 6 months	Measure MLFHQ scores for all patients
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.	At baseline, 1 month and 6 months	* 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
To evaluate the change in patient reported quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ))	At baseline, and post intervention at 1 month and 6 months	Measure Kansas City Cardiomyopathy Questionnaire scores for all patients

Trial Locations

Locations (1)

Barts Health NHS Trust; 🇬🇧 London, England, United Kingdom