Clinical trial NCT03193021: AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
Official title: AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Keywords: vessel closure
venous access site
femoral venotomy
medium bore
multiple access sites
Lead sponsor: Cardiva Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
Primary purpose: TREATMENT

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.

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, 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

Primary outcomes:
measure: Time to Ambulation (TTA)
timeFrame: Post-procedure, usually within 6 hours
measure: Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
timeFrame: 30 +/- 7 days post-procedure
Secondary outcomes:
measure: Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
timeFrame: 30 +/- 7 days post-procedure
measure: Time to Discharge Eligibility (TTDE)
timeFrame: Prior to hospital discharge, usually within 24 hours
measure: Time to Hemostasis (TTH)
timeFrame: Post-procedure, usually within 3 hours
measure: Time to Discharge (TTD)
timeFrame: Prior to hospital discharge, usually within 24 hours
measure: Time to Closure Eligibility (TTCE)
timeFrame: Post-procedure, usually within 6 hours
measure: Total Post-Procedure Time (TPPT)
timeFrame: Post-procedure, usually within 6 hours
measure: Number of Participants With Procedure Success
timeFrame: 30 +/- 7 days post-procedure
measure: Number of Access Sites With Device Success
timeFrame: Procedural, usually within 15 minutes of enrollment
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart & Vascular
state: Alaska
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory St. Joseph's Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Murray
country: United States
facility: Intermountain Health Care
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alaska Heart Institute
name: Steve Compton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Center for Clinical Research
name: Mintu Turakhia, MD
role: STUDY_DIRECTOR
References:
citation: Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.