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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgical Wound
- Sponsor
- Cardiva Medical, Inc.
- Enrollment
- 168
- Locations
- 3
- Primary Endpoint
- Number of Participants With Overall Procedure Success - Effectiveness
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •No Urinary Catheter: Candidate to undergo the procedure and bedrest without a urinary catheter
- •No Protamine: Candidate to receive procedural heparin for anti-coagulation management.
- •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
- •Pre-Operative
Exclusion Criteria
- •Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the index procedure:
- •Advanced refusal of blood transfusion, if it should become necessary;
- •Active systemic infection, or cutaneous infection or inflammation in the vicinity of the groin;
- •Pre-existing immunodeficiency disorder and/or chronic use of high dose systemic steroids;
- •Known history of bleeding diathesis, coagulopathy, hypercoagulability, or current platelet count \< 100,000 cells/mm3;
- •Severe co-existing morbidities, with a life expectancy of less than 12 months;
- •Currently involved in any other investigational clinical trial that may interfere with the outcomes of this study in the opinion of investigator;
- •Femoral arteriotomy in either limb with any of the following conditions:
- •access within \< 10 days
- •any residual hematoma, significant bruising, or known associated vascular complications
Outcomes
Primary Outcomes
Number of Participants With Overall Procedure Success - Effectiveness
Time Frame: 30 (+/- 10) days post-procedure
Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up
Major Venous Access Site Closure-related Complications - Safety, Number of Limbs With Each Event
Time Frame: 30 (+/- 10) days post-procedure
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.
Secondary Outcomes
- Study Group Success Rate - No Urinary Catheter Group, Number of Participants(From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis)
- Study Group Success Rate - Same Calendar Day Discharge Group, Number of Participants(Within 72 hours post-discharge)
- Study Group Success Rate - No Protamine Group, Number of Participants(From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis)
- Number of Devices With Success(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(30 (+/- 10) days post-procedure)