TRICAR V1.0
Research type
Research Study
Full title
A Single Centre, Prospective, Single Arm Open Label Case Series of the TRICENTO, a Transcatheter Tricuspid Valved Stent Graft for Reduction of Tricuspid Regurgitation and Improved Patient Reported Outcomes in Patients with Carcinoid Heart Disease.
IRAS ID
262072
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Queen Mary University London
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
Does the Tricento Tricuspid Valve System improve symptoms and quality of life in adults who have severe tricuspid regurgitation due to carcinoid heart disease?
Tricuspid regurgitation (TR) is a leaky tricuspid valve on the right side of the heart. Many conditions can cause severe TR. Carcinoid heart disease (CHD), a form of cancer affecting the heart is one such condition. Patients suffer many unpleasant symptoms such as swelling of legs, tiredness, lack of energy and being out of breath. They experience loss of quality of life. For many there are no other surgical or medical treatments to reduce the symptoms.
A new technology, the TRICENTO Valved Stent Graft System, is a custom-made valve implant. It seems to be a low risk alternative to tricuspid valve surgery and helpful to patients with no other options. Reports from the first valve implants suggest patients feel better as early as 24 hours.
In this study we will
See how well this new valve relieves symptoms in patients with CHD and TR.
See how safe and effective it is.
Increase our understanding of how the valve works.Barts Charity is funding the study at Barts Health NHS Trust. 15 patients with symptoms of TR and CHD will have this new valve. The custom-made valve is put into the right side of the heart via a vein in the groin. The procedure takes about 45 minutes. We will take various measurements, scans, and questionnaires before and after. We follow the patient for 6 months with clinic visits and collect data from medical records up to 3 years after the valve implant.
We hope that as well as improving symptoms and quality of life, it may extend life expectancy. The new valve could change treatment for patients with severe TR caused by many other conditions.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0286
Date of REC Opinion
1 Feb 2022
REC opinion
Further Information Favourable Opinion