Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that new data from the randomized 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 randomized, multi-center 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 (6-12 Fr inner diameter sheath) venous access sites.
Details of the presentation include:
- Session LBP.02 – New Trials in Cardiovascular Care
– Venous Vascular Closure System (VVCS) vs. Manual Compression (MC) for EP Catheter Ablation: The AMBULATE Randomized Trial
Presented by lead author Dr. Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute, on Saturday, November 10 at 9:45 a.m. CT in room N228
Twenty-eight physicians enrolled 204 patients in the AMBULATE pivotal trial at 13 sites across the United States. Principal investigators include Dr. Andrea Natale; Dr. Mintu Turakhia, associate professor, Stanford University School of Medicine; and Dr. Steve Compton, Alaska Heart and Vascular Institute.
VASCADE MVP is a fully integrated, extravascular, bioabsorbable femoral venous access closure system that is easy to use and leaves no permanent components behind. The system combines Cardiva’s proven proprietary collapsible disc technology and a thrombogenic resorbable collagen patch in an integrated design.
VASCADE MVP works by placing a small, collapsible mesh disc against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue and then removing the mesh disc. The collagen patch expands, providing a mechanical and physiological seal to stop the bleeding, and then absorbs into the body, leaving nothing behind and allowing further access to the vessel if additional procedures are required.
The VASCADE MVP System is a new, investigational device built upon the established and clinically proven VASCADE system.