Ambulate is a portfolio of clinical, economic, and workflow studies designed to better understand the implications of post procedure care for AF ablation patients using the VASCADE® MVP1 Venous Vascular Closure System (VVCS).

The portfolio is comprised of the AMBULATE US Pivotal Trial, AMBULATE CE Mark Study2, AMBULATE CAP Study (Continued Access Protocol), and AMBULATE IMPACT Study (workflow & economics).

Principal Investigators

  • Andrea Natale, MD (Texas Cardiac Arrhythmia Institute – Austin, TX)
  • Steve Compton, MD (Alaska Heart & Vascular Institute – Anchorage, AK)
  • Mintu Turakhia, MD (Stanford Center for Clinical Research – Palo Alto, CA)

Primary Objectives

  • Demonstrate the safety and effectiveness of the Cardiva VASCADE® MVP Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 – 12F introducer sheaths.

Study Design

  • Prospective, multi-center, randomized
  • Randomized 1:1 with approximately 204 patients
  • Targeting EP Procedures with 3 to 4 venous access sites
  • 13 enrolled centers

Safety Endpoints

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

Primary Effectiveness Endpoint

  • Time To Ambulation (TTA)

Secondary Effectiveness Endpoint

  • Time To Discharge eligibility (TTDE)
  • Total Post Procedure Time (TPPT)
  • Procedure success
  • Device success

Additional Data Collection Elements

  • Patient Satisfaction Survey
  • Pain Medication Usage
  • Same Calendar Day Discharge

Important Notes

  • VASCADE® MVP is an investigational device that is not commercially available for sale
  • AMBULATE STUDY is governed under IDE G170144 in the United States
  • ClinicalTrials.gov ID is NCT03193021

1. VASCADE® MVP is an investigational device and not commercially available for sale or distribution.
2. CE Mark pending, results being released in conjunction and coordination with notified body.

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