Primary Objectives

Objective of the AMBULATE CAP Study is to demonstrate the safety and effectiveness of the Cardiva VASCADE® MVP Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures performed through 6 – 12 F introducer sheaths, while allowing for one or more of the following: elimination of the Foley catheter, elimination of protamine, or allowing same (calendar) day discharge for the appropriate patient population.

Study Design

  • Prospective, multi-center, single-arm
  • Up to 500 patients and 5 centers (Limited to AMBULATE US Pivotal Study enrolling centers)
  • Targeting EP Ablation Procedures

Safety Endpoints

Rate of combined major (primary) and minor (secondary) venous access site closure-related complications through 30 days

Primary Effectiveness Endpoint

Combined Rate of Procedure Success

Secondary Effectiveness Endpoints

  • No Foley Success Rate
  • No Protamine Success Rate
  • Same Calendar Day Discharge Success Rate

Important Notes

  • VASCADE® MVP is an investigational device not commercially available for sale.
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