Transforming Aortic Stenosis Treatment with Novel Biomimetic THV
PARADIGM Trial Design and Early DurAVR® THV Experience
This two part peer-to-peer discussion with Prof Ole De Backer (Copenhagen, DK) and Prof Nicolas van Mieghem (Rotterdam, NL) offers key insights into the evolving landscape of TAVI therapy.
Part one provides a concise overview of the PARADIGM trial, a head-to-head TAVI trial comparing the biomimetic DurAVR® THV to contemporary TAVI valves in an all-comers patient population. It is the first head-to-head trial to assess post-TAVI flow using cardiac MRI, delivering an unprecedented perspective on hemodynamic performance, flow characteristics, and LV mass regression after valve implantation. With over 80 enrolling centers across the US, Canada, and Europe, recent FDA IDE approval, and the first enrollment in October 2025, the PARADIGM trial is positioned fro rapid recruitment to support future commercial approval of the DurAVR® THV across all risk levels.
Part two features Prof Ole De Backer sharing the 30-day outcomes from the first 100 DurAVR® patients with small aortic annuli, offering early insight into clinical performance. The discussion concludes by emphasizing how these results reinforce the importance of the PARADIGM trial and its role in shaping the future of TAVI - with a flow on flow restoration to improve long-term patient outcomes.
DurAVR® INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE.
EU: For clinical investigations only.
US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
Learning Objectives
- Learn about the PARADIGM Trial and how it is a first-of-its-kind in TAVI
- Discover how the DurAVR® biomimetic THV is designed to restore physiologic flow for better patient outcomes, including restored healthy LV function and enhanced valve durability
- Discuss the DurAVR® outcomes in 100 small aortic annulus patients
Target Audience
- Interventional Cardiologists
- Cardiothoracic Surgeons
- HCPs in Training
More from this programme
Part 1
PARADIGM Trial
Part one provides a concise overview of the PARADIGM trial, a head-to-head TAVI trial comparing the biomimetic DurAVR® THV to contemporary TAVI valves in an all-comers patient population. It is the first head-to-head trial to assess post-TAVI flow using cardiac MRI, delivering an unprecedented perspective on hemodynamic performance, flow characteristics, and LV mass regression after valve implantation. With over 80 enrolling centers across the US, Canada, and Europe, recent FDA IDE approval, and the first enrollment in October 2025, the PARADIGM trial is positioned fro rapid recruitment to support future commercial approval of the DurAVR® THV across all risk levels.
| 1 session | |
| PARADIGM Trial | Watch now |
Part 2
DurAVR 30-Day Outcomes in 100 Patients
Part two features Prof Ole De Backer sharing the 30-day outcomes from the first 100 DurAVR® patients with small aortic annuli, offering early insight into clinical performance. The discussion concludes by emphasizing how these results reinforce the importance of the PARADIGM trial and its role in shaping the future of TAVI - with a flow on flow restoration to improve long-term patient outcomes.
Faculty Biographies
Ole De Backer
Professor of Medicine and Cardiology
Professor Ole De Backer is an internationally renowned interventional cardiologist based in Copenhagen, Denmark. He works at Rigshospitalet, Copenhagen University Hospital, where he is actively involved in the treatment of patients with complex structural heart disease. He has built an international reputation through his clinical expertise, research leadership, and commitment to innovation in minimally invasive cardiovascular interventions.
Academic History
Professor De Backer has developed an academic career centred on interventional cardiology and structural heart disease. His work integrates clinical practice with research and technological development, particularly in the application of advanced imaging and percutaneous techniques. He has been actively involved in training and mentoring clinicians in the evolving field of transcatheter heart interventions.
Career Overview
Professor Ole De Backer is a leading expert in…
Nicolas M Van Mieghem
Full Professor of Interventional Cardiology
Prof Van Mieghem initially intended to train as a cardiac surgeon but decided to specialise in interventional cardiology instead, following advice from a mentor. This decision was cemented when he read the first-in-human case report of transcatheter aortic valve implantation (TAVI) in Circulation by Alain Cribier in 2002. Prof Van Mieghem believes that great cardiologist genuinely cares for their patients. He names Gary Roubin, Dr Manu Malbrain and Professor Patrick Serruys among his mentors.
Academic History
Prof. Nicolas M. Van Mieghem completed his medical training at the Catholic University of Leuven (Belgium), where he earned both his medical degree and his specialist degree in cardiology. During his time in Leuven, he developed a strong interest in cardiovascular medicine, particularly in the emerging field of minimally invasive cardiac interventions. After finishing his core medical and cardiology training, he pursued multiple advanced…
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