NCT03573206

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

Multi-center, Single Arm Continued Access Protocol to Evaluate the Mid-Bore Venous VCS for the Management of the Femoral Venotomy After Catheter-based Interventions Via 6-12F Procedural Sheaths With Single or Multiple Access Sites Per Limb

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Cardiva Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

A prospective multi-center, single arm continued access clinical protocol enrolling subjects with multiple femoral venous access sites. All femoral venous access sites will be closed using the Cardiva Mid-Bore VVCS. Subjects will be prospectively evaluated for eligibility in the three study groups in order to answer specific research questions related to safety and effectiveness of the device as it relates to the use of peri-procedural urinary catheters, protamine for reversal of heparin, and same calendar day discharge in a select group of procedure types.

Conditions

• Surgical Wound

Interventions

Type	Name	Description
DEVICE	Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)	The device will be used to close all femoral venous access sites at the end of the case.

Timeline

• Start date: 2018-08-27
• Primary completion: 2019-01-14
• Completion: 2019-03-31
• First posted: 2018-06-29
• Last updated: 2023-03-10
• Results posted: 2020-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study