Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT04671758
Brief Summary:
The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.
Detailed Description:
Up to now, the balloon-expandable valves have been considered contraindicated for patients with pure AR due to the absence of calcium which is considered necessary for the anchoring of the prosthesis. Nonetheless, several cases report have suggested the feasibility of TAVI using the SAPIEN XT THV, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses.
The new generation balloon-expandable SAPIEN 3 THV has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. These characteristics of the SAPIEN 3 THV might translate into a safer use of this device in patients with pure AR and non-calcified valves.
Significant AR occurs in 2.0% of individuals of \>75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. As for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. Although patients with severe AR have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant AR finally undergo intervention. Reasons for no intervention are unknown.
Even if it has been suggested that AR might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure AR is a small niche of patients for TAVI. In terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. However, performing TAVI with a device used in the routine practice might be appealing and, importantly, safer. A preliminary case series including 3 patients have suggested the feasibility of TAVI with the SAPIEN 3 device for pure AR (Urena M, Himbert D. JACC, 2016 ). In this study we aim to evaluate the feasibility and long-term safety of the SAPIEN 3 THV in patients with pure AR.
Study:
NCT04671758
Study Brief:
Protocol Section:
NCT04671758