FOLLOW Study
Research type
Research Study
Full title
Clinical outcomes of the NVT ALLEGRA TAVI System TF in failing calcified aortic heart valves in a real-world patient population with elevated surgical risk.
IRAS ID
297705
Contact name
Ayush Khurana
Contact email
Sponsor organisation
NVT GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Increased life expectancy has resulted in an older population and consequently an increased number of patients with degenerative calcified aortic valve stenosis. Degenerative aortic valve stenosis is the most common valvular problem in adults in Western industrialized countries. When first symptoms appear, such as angina, syncope, and dyspnea appear, the prognosis is poor. Clinical studies report a mortality rate of 25% in the first year and 50% in the second year after the onset of symptoms, despite drug therapy. Open surgical aortic valve replacement with biological or mechanical prostheses has been the treatment of choice to date. However, many of these patients are too ill to undergo an open heart procedure or have concomitant diseases that exclude surgical aortic valve replacement.
The minimally invasive technique (TAVI) avoids the need for sternotomy and cardiopulmonary bypass and, therefore, provides a treatment option for patients who are at increased risk for surgical valve replacement. Nowadays, TAVI has been established as a standardized interventional procedure with a predictable risk, which is why the number of implanted TAVI prostheses has also increased significantly in the last decade.The FOLLOW study evaluates the ALLEGRA TAVI System TF and corresponds to an observational, prospective, multicenter, single-arm, post-market study with protocol-defined in-hospital follow-up visits after 30 days, 12 and 24 months. All eligibility criteria of the study are based on the current Instructions for Use (IFU) of this CE-marked TAVI System. This device is designed to replace a severe calcified stenotic native aortic heart valve or a failing surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve.
The main goal of the study is to collect real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluate early and midterm clinical and quality of life outcome.REC name
London - Surrey Research Ethics Committee
REC reference
21/PR/1196
Date of REC Opinion
16 Dec 2021
REC opinion
Further Information Favourable Opinion