ClinicalTrials.gov
ClinicalTrials.gov Menu

The AMBULATE Trial: A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes (AMBULATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193021
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Stanford Center for Clinical Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Device: Cardiva Mid-Bore VVCS Other: Manual compression Not Applicable

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  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: Data Safety Monitoring Committee will adjudicate endpoint events, blinded to treatment assignment when possible
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) v. Manual Compression for the Management of the Femoral Venotomy After Catheter-based Interventions Performed Via 6-12 Fr Procedural Sheaths With Single or Multiple Access Sites Per Limb
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : April 13, 2018
Actual Study Completion Date : April 13, 2018

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.




Primary Outcome Measures :
  1. Time to Ambulation (TTA) [ Time Frame: 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.

  2. Major venous access site closure-related complications [ Time Frame: 30 +/- 7 days post-procedure ]
    Rate of combined major venous access site closure-related complications attributed directly to the closure method.


Secondary Outcome Measures :
  1. Minor venous access site closure-related complications [ Time Frame: 30 +/- 7 days post-procedure ]
    Rate of combined minor venous access site closure-related complications attributed directly to the closure method.

  2. Time to Discharge Eligibility (TTDE) [ Time Frame: 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

  3. Time to Hemostasis (TTH) [ Time Frame: 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.

  4. Time to Discharge (TTD) [ Time Frame: 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

  5. Time to Closure Eligibility (TTCE) [ Time Frame: 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)

  6. Total Post-Procedure Time (TPPT) [ Time Frame: 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

  7. Procedure Success [ Time Frame: 30 +/- 7 days post-procedure ]
    Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications

  8. Device Success [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193021


Locations
United States, Alaska
Alaska Heart & Vascular
Anchorage, Alaska, United States, 99508
United States, California
Mercy General Hospital
Sacramento, California, United States, 95819
Stanford University Hospital
Stanford, California, United States, 94305
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Tennessee
Centennial Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
United States, Utah
Intermountain Health Care
Murray, Utah, United States, 84107
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Cardiva Medical, Inc.
Stanford Center for Clinical Research
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Steve Compton, MD Alaska Heart Institute
Study Director: Mintu Turakhia, MD Stanford Center for Clinical Research

Responsible Party: Cardiva Medical, Inc.
ClinicalTrials.gov Identifier: NCT03193021     History of Changes
Other Study ID Numbers: PTL 0508
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Cardiva Medical, Inc.:
vessel closure
venous access site
femoral venotomy
medium bore
multiple access sites

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries