Clinical trials

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery. The DefiPace registry is designed in two phases 1. to document the standard of care in 50 patients with atrial fibrillation (AF) 2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.

A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI). The main aims are: * to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications * if valve size was identical to the one determined using the circle method compared to * a case where circle method derived valve size is different from the actually implanted valve * to develop recommendations on how to size the valve using the circle method.