ET-TEER Version 1.0
Research type
Research Study
Full title
Changes in Exercise capacity, right ventricular function, activity levels and quality of life following transcatheter edge to edge repair in patients with severe tricuspid regurgitation.
IRAS ID
340757
Contact name
R&D Office
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
The tricuspid valve (TV) is the first valve found in the heart when blood returns from the body to the heart. Blood travels through the TV into the right ventricle (RV), the pumping chamber that forces blood into the lungs. Heart valves ensure blood flows in one direction. Should the TV not close properly, blood leaks backwards into the body's major veins and a diagnosis of tricuspid regurgitation (TR) is made. TR can be graded on a spectrum - from minor to severe where a significant blood flows in the wrong direction. This causes a range of detrimental effects, including leg swelling, liver and liver dysfunction, shortness of breath and reduced exercise tolerance.
Treatment options have historically been limited to a symptomatic approach (medical management, non-curative) or open-heart surgery (opening the chest to access the heart to repair or replace the valve). Open-heart surgery is a major operation and carries a significant risk of complications making it not a viable for many patients with TR. Recently, transcatheter edge-to-edge repair (TEER) has emerged as an alternative therapeutic intervention.
TEER is a minimally invasive procedure, using a catheter (a thin, flexible tube), inserted through a vein to reach the TV. The catheter carries a tiny device that clips the edges of the valve together to reduce the leak, helping the heart pump blood more efficiently.
Our study aims to understand how TEER benefits patients with severe TR. We will assess how it impacts patient important outcomes, including quality of life and exercise capacity, as well as the function of the RV of the heart.
Moreover, by identifying the most reliable tests, we hope to accurately predict which patients will benefit most from T-TEER. This knowledge will enable doctors to better advise patients, allowing for more informed decisions about their care options.
REC name
Wales REC 7
REC reference
24/WA/0153
Date of REC Opinion
4 Jun 2024
REC opinion
Further Information Favourable Opinion