Cardiva Medical, an innovator in the field of vascular closure, has announced that new data from the randomised AMBULATE study will be presented in a late-breaking session on new trials in cardiovascular care at Scientific Sessions 2018, the annual medical meeting of the American Heart Association (AHA) in Chicago.
AMBULATE is a randomised, multicentre pivotal study evaluating the VASCADE MVP system compared to manual compression for multi-access, catheter-based procedures such as cardiac ablation for atrial fibrillation. The endpoint of the trial is to demonstrate significantly reduced time-to-ambulation for patients following these common and high-growth electrophysiology procedures. The AMBULATE pivotal trial is one of several clinical trials in the company’s AMBULATE series that are studying the VASCADE MVP venous vascular closure system for use in the closure of mid-bore (6-12F inner diameter sheath) venous access sites.
Details of the presentation include:
Session: New Trials in Cardiovascular Care
– Venous Vascular Closure System (VVCS) versus Manual Compression (MC) for EP Catheter Ablation: The AMBULATE Randomized Trial
Presented by lead author Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute, on the 10th of November.
Twenty-eight physicians enrolled 204 patients in the AMBULATE pivotal trial at 13 sites across the USA. Principal investigators include Andrea Natale; Mintu Turakhia, associate professor, Stanford University School of Medicine (Stanford, USA); and Steve Compton, Alaska Heart and Vascular Institute, Anchorage, USA.