Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royal Free Hospital NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Tricuspid Valved Stent Graft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 pre intervention and immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
|
Not provided
General Inclusion Criteria
General Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Baumbach | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | England | E1 1BB | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft
Not provided
Not provided
Not provided
Not provided
|
|
| At baseline, 1 month and 6 months |
| •To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score | •NYHA assessment | At baseline, and post intervention at 1 month and 6 months |
| To evaluate the change in peripheral oedema experienced by patients |
| 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 | 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 | 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 | 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 | At baseline, and post intervention at 1 month and 6 months |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D020230 | Serotonin Syndrome |
| D002275 | Carcinoid Heart Disease |
| D002276 | Carcinoid Tumor |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D008303 | Malignant Carcinoid Syndrome |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided