AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)

Completed · Not applicable

Conditions studied: Surgical Wound

In brief

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.

Key facts

Study ID

NCT03573206

Run by

Cardiva Medical, Inc.

People needed

168

Starts

2018-08-27

Expected to finish

2019-03-31

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Emory St. Joseph's Hospital — Atlanta, Georgia, United States
• Valley Hospital — Ridgewood, New Jersey, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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