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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
168
The device will be used to close all femoral venous access sites at the end of the case.
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
Number of Participants With Overall Procedure Success - Effectiveness
Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up
Time frame: 30 (+/- 10) days post-procedure
Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event
Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 (+/- 10) days post-procedure
Study Group Success Rate - No Urinary Catheter Group, Number of Participants
No peri-procedural urinary catheter insertion required through successful Ambulation (per-patient analyses)
Time frame: From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis
Study Group Success Rate - No Protamine Group, Number of Participants
No delay in Ambulation due to access site bleeding in subjects who receive heparin but are not reversed with protamine (per-patient analyses)
Time frame: From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis
Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants
Discharge within the same calendar day from the start of the procedure without the need for re-hospitalization within 72 hours of hospital discharge due to access site complications (per-patient analyses)
Time frame: Within 72 hours post-discharge
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Number of Devices With Success
The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per-access site analyses)
Time frame: Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered "minor" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Time frame: 30 (+/- 10) days post-procedure