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

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 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.

Key facts

Study ID

NCT03193021

Run by

Cardiva Medical, Inc.

People needed

204

Starts

2017-09-20

Expected to finish

2018-04-13

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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