The trial will enroll patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair (TEER). The trial is designed with two separate non-randomised cohorts, which include moderate/severe mitral annular calcification (MAC), and a primary cohort that will include patients with no or mild MAC.
“The AltaValve System is the first atrial fixation transcatheter mitral valve replacement (TMVR) device that is designed to minimise challenges of the sub-valvular TMVRs, especially screen failures associated with the risk of left ventricular outflow tract obstruction, damage to the left ventricle and MAC,” said Ron Waksman (Medstar Washington Hospital Center, Washington, DC, USA), steering committee chair for the ATLAS trial.
“We are excited to have successfully enrolled the first US patients in the ATLAS trial. I am particularly excited as the AltaValve System is designed to offer the broadest applicability for wide range of pathologies,” said Paul Sorajja (Minneapolis Heart Institute, Minneapolis, USA), co-principal investigator (PI) of the trial. “It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide.”
Yoshi Kaneko (Barnes-Jewish Hospital, St Louis, USA), shares co-PI responsibilities with Sorajja in USA, while Vlasis Ninios (Interbalkan Medical Center, Thessaloniki, Greece) and Lenard Conradi (University Hospital Cologne, Cologne, Germany), share Co-PI responsibilities in Europe.
“It takes significant dedication and a lot of teamwork to take an innovative solution to treat MR from ideation to a global pivotal trial. We are very grateful for such strong support from key opinion leaders worldwide who are helping us carry our novel AltaValve system through pivotal trial with a goal of delivering safe and effective treatment solution for patients suffering from MR,” said Saravana Kumar, CEO and President at 4C Medical.
