The first patient is a milestone for any clinical trial. The joint work of the clinical investigators, the study centres and the project managers of IHF GmbH begins with the first patient. This time, the Ludwigs-Maximilians-University Clinic kicked off the project: The clinical trial team of Prof. Dr. Steffen Massberg admitted the first patient to the study. REBOOT PARADOX is the first clinical study to systematically benchmark therapies for paradoxical aortic valve stenosis. Previous investigations have shown that the prognosis for patients with reduction of the aortic valve area can be significantly improved by aortic valve replacement. However, there is still no sufficient database for a reliable recommended treatment. Directed by Prof Julinda Mehilli (Munich), the clinical study focuses for the first time on the particular medical conditions of paradoxical aortic valve stenosis. The study includes two patient groups, one of which is drug-adjusted and one has an artificial heart valve. The IHF GmbH team would like to wish the very first and future patients an early recovery and an improved health with a great quality-of-life.
The ethics committee has evaluated the clinical investigation plan and has provided favourable opinion for the PASSPORT-HF study without further requirements.Read more
Supported by the Ministry of Social Affairs, Labour, Health and Demography of Rhineland-Palatinate, IHF GmbH manages the COVID-19-Registry Rhineland-Palatinate, which was launched this weekend. Registry for Rhineland-Palatinate for the documentation...Read more
Commissioned by the Federal Joint Committee (G-BA), IHF GmbH is running one of the first studies on benefit assessment of a medical device in accordance with the directive § 137e Social Security Code Book V (SGB V).Read more