Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study. This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic...
Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions). Transcatheter aortic valve implantation...
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves...
The purpose of the SAPIEN 3 study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement. This...
The objective of the MAVERIC study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF). ClinicalTrials.gov ID NCT02302872
A Prospective, multi-center study to evaluate the safety and performance of the Hyperion™ ASD, PDA and VSD Closure Systems. The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD, PDA and VSD patients. ClinicalTrials...
The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method. Use of temporary pacing via a right ventricular...
Activation is a prospective randomised (1 :1) controlled study to test the hypothesis that revascularisation of significant coronary artery disease by Percutaneous Coronary Intervention prior to Transcatheter Aortic Valve Implantation (TAVI) will result in rate of mortality and re-hospitalisation at...
The objective of ACURATE IDE is to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. ID: NCT03735667 Last publication: ACURATE neo2 valve...
MENA TAVI is a single arm, prospective, open label and multicenter registry. The objective is to evaluate the ACURATE NEO 2 in the Middle East population suffering from severe symptomatic aortic stenosis. The objective is to enroll 100 patients from 6 investigational sites and patients will be...
