Clinical studies (overview)

We conduct several clinical studies, in particular for heart valves and drugs. Below is a selection of our current studies.

Study (year 2014) Study design
AVERT St. Jude
Medical
Artificial Valve Endocarditis Reduction Trial: independent, multi-year, multi-center randomized study intended to study the efficacy of silver coating on the valve sewing cuff fabric in reducing the incidence of prosthetic valve endocarditis
Enable I long term
Follow-up
The primary objective of the study is to evaluate the safety and
effectiveness of the Medtronic ATS Enable™ Aortic Bioprosthesis
during long-term follow-up
EASE Studie Enable Aortic Sutureless Bioprosthesis Evaluation, nonrandomized,
prospective, non-interventional multicenter post
market release (PMR) study
Perceval Pivotal
Trial
Prospective, multicenter, European, non-randomized. Sutureless,
bovine pericardial stented bioprosthesis
Cavalier Pivotal
Trial
Perceval S valve clinical trial for extended CE mark
Freedom Solo
Stentless Heart
Valve Sorin
Biomedica Cardio
s.r.l.
Prospective, non-randomized, multicenter trial (CE marked May
2004) Stentless aortic valve made of bovine pericardium
FOUNDATION Assessing standard of care and clinical outcomes using the
Edwards intuity valve system in a European multicenter, active,
post-market surveillance study. Prospective, single arm, multicenter
study.
SURTAVI SURTAVI Surgical Replacement and Transcatheter Aortic Valve
Implantation. Subject will be randomized on a 1:1 basis to either
transcatheter aortic valve implant (TAVI) with the Medtronic
CoreValve® System (MCS) or to surgical aortic valve replacement
Perigon PERIcardial SurGical Aortic Valve ReplacemeNt Pivotal Trial
(PERIGON)
Cathar Comparison of antithrombotic treatments after aortic valve
replacement. Rivaroxaban: A new Antithrombotic Treatment for
Patients with Mechanical Prostesic Aortic Heart Valve
Swiss-TAVIRegistry Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
SAVI 2 Symetis ACURATE TA™ Valve Implantation Register 2:SAVI 2
CardioGard A study to collect additional information related to the safety and
performance of the CardioGard cannula
eMesh A multicenter, randomized study of external saphenous vein
support using eSVS Mesh in CABAG Surgery
Metabolomics Metabolic factors positively associated with the non-development of
coronary artery disease
EAGLE Registry Endurant for Challenging Anatomy: Global Experience Registry
Thoraflex™ Hybrid To monitor the post-market clinical safety and performance of the Vascutek Thoraflex™ Hybrid Graft in patients requiring a “frozen Elephant Trunk” procedure to replace the aortic arch and repair aneurysm and/or dissection of the descending aorta in a single surgical procedure. All patients implanted with a Vascutek Thoraflex™ Hybrid Device and who consent to the use of their data will be included in the registry.