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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound
• Intervention / Treatment: Device: Cardiva Mid-Bore VVCS; Other: Manual compression

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart & Vascular
  • California
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Stanford, California, United States, 94305
      • Stanford University Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory St. Joseph's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Health Care
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiva Mid-Bore VVCS; Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.	Device: Cardiva Mid-Bore VVCS; The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.
Active Comparator: 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.	Other: Manual compression; Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Ambulation (TTA)	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.	Post-procedure, usually within 6 hours
Major Venous Access Site Closure-related Complications, 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.	30 +/- 7 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discharge Eligibility (TTDE)	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	Prior to hospital discharge, usually within 24 hours
Time to Hemostasis (TTH)	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.	Post-procedure, usually within 3 hours
Time to Discharge (TTD)	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	Prior to hospital discharge, usually within 24 hours
Time to Closure Eligibility (TTCE)	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)	Post-procedure, usually within 6 hours
Total Post-Procedure Time (TPPT)	Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate	Post-procedure, usually within 6 hours
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.	30 +/- 7 days post-procedure
Number of Participants With Procedure Success	Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications	30 +/- 7 days post-procedure
Number of Access Sites With Device Success	Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)	Procedural, usually within 15 minutes of enrollment

Collaborators and Investigators

• Sponsor: Cardiva Medical, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: vessel closure; venous access site; femoral venotomy; medium bore; multiple access sites
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: PTL 0508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes