AMBULATE CAP

Multi-Center, Single Arm Continuing Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) for the Management of the Femoral Venotomy After Catheter-based Interventions Performed Via 6-12 Fr Procedural Sheaths With Single or Multiple Access Sites Per Limb

Objective

The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, 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.

Eligibility

  • Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath
  • Must be eligible for at least one of the study groups:
    1. No Urinary Catheter: Candidate to undergo the procedure and bedrest without a urinary catheter
    2. No Protamine: Candidate to receive procedural heparin for anti-coagulation management
    3. Same Calendar Day Discharge: Expected to undergo a procedure for Supraventricular Tachycardia, Atrial Flutter, Atrial Fibrillation or Ventricular Tachycardia; if heparin is planned, it must be reversed with protamine; and physician is expected to be on site for discharge evaluation

NCT ID

NCT03573206