AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID

Not Applicable

Completed

Conditions: Surgical Wound

Interventions: Other: Manual compression
Device: Cardiva Mid-Bore VVCS

Registration Number: NCT03193021

Lead Sponsor: Cardiva Medical, Inc.

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 and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.

Detailed Description: A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.

Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 204

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, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
Anticipated prolonged bedrest (5 hours or more) and / or overnight stay

Exclusion Criteria

Active systemic or cutaneous infection, or inflammation in vicinity of the groin
Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
Severe co-existing morbidities with life expectancy less than 12 months
Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
Planned femoral venous or arterial access within next 30 days
History of DVT, pulmonary embolism or thrombophlebitis
Significant anemia or renal insufficiency
BMI > 45 kg/m2 or < 20 kg/m2
Unable to routinely walk at least 20 ft. without assistance
LMWH within 8 hours before or after procedure
Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; < 6 Fr or > 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be < 2.5 cm deep

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Compression	Manual compression	Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.
Cardiva Mid-Bore VVCS	Cardiva Mid-Bore VVCS	Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.

Primary Outcome Measures

Name	Time	Method
Time to Ambulation (TTA)	Post-procedure, usually within 6 hours	Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event	30 +/- 7 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 Outcome Measures

Name	Time	Method
Time to Discharge (TTD)	Prior to hospital discharge, usually within 24 hours	Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged
Number of Participants With Procedure Success	30 +/- 7 days post-procedure	Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event	30 +/- 7 days post-procedure	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.
Total Post-Procedure Time (TPPT)	Post-procedure, usually within 6 hours	Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time to Discharge Eligibility (TTDE)	Prior to hospital discharge, usually within 24 hours	Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site
Time to Hemostasis (TTH)	Post-procedure, usually within 3 hours	Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.
Time to Closure Eligibility (TTCE)	Post-procedure, usually within 6 hours	Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)
Number of Access Sites With Device Success	Procedural, usually within 15 minutes of enrollment	Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)

Trial Locations

Locations (13): Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
Alaska Heart & Vascular
🇺🇸
Anchorage, Alaska, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
Stanford University Hospital
🇺🇸
Stanford, California, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
Emory St. Joseph's Hospital
🇺🇸
Atlanta, Georgia, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Intermountain Health Care
🇺🇸
Murray, Utah, United States
University of Utah Health Sciences Center
🇺🇸
Salt Lake City, Utah, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States