POPular PET TAVI
Research type
Research Study
Full title
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
IRAS ID
327157
Contact name
M. Dweck
Contact email
Sponsor organisation
St. Antonius Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
In patients with severe narrowing of the aortic valve (aortic stenosis), a bioprosthetic valve can be placed using a minimal-invasive technique, called transcatheter aortic valve implantation (TAVI). After a TAVI procedure, small blood clots can attach to the implanted heart valve. This occurs in approximately 15-30% of the patients. Usually this is mild and patients do not immediately notice this. But over the years, this may lead to (accelerated) wear and tear of the valve, causing the heart valve to narrow again or to leak. This can lead to complaints such as shortness of breath, fatigue or chest pain. Ultimately, a re-operation or re-intervention on the valve may be needed, or in the worst case, the patient may die from heart failure. In order to be able to find effective treatments to prevent or slow down this wear and tear process, understanding the underlying mechanisms and risk factors of this degeneration process is crucial.
To study this process, patients who underwent a successful TAVI procedure about five years ago, who are eligible and willing to participate, will be invited to undergo the following imaging procedures: 1. Echocardiography (standard imaging investigation in the NHS), and 2. Hybrid Positron Emission Tomography (PET) - Computed Tomography (CT). For the PET scan the radiotracer 18F-sodium fluoride will be used (a colourless liquid injected into a vein in order to visualize degeneration). This radiotracer has been used in recent research studies investigating heart valve diseases. This will help us to measure the degree of wear and tear of the valves; compare this between patients with and without blood clots on the implanted valve, between different valve types, and evaluate the impact of other local valve related factors.
We plan to recruit 180 patients for this cross-sectional study, in which participants undergo the mentioned imaging procedures, without any further follow-up.
REC name
North of Scotland Research Ethics Committee 2
REC reference
24/NS/0001
Date of REC Opinion
17 Jan 2024
REC opinion
Unfavourable Opinion