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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)

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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.

Tracking Information
First Submitted Date  ICMJE June 16, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date April 20, 2018
Actual Study Start Date  ICMJE September 20, 2017
Actual Primary Completion Date April 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03193021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • 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.
  • 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
  • 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.
  • 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
  • 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)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Surgical Wound
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Cardiva Mid-Bore VVCS
  • 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.
    Intervention: Other: Manual compression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
204
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 13, 2018
Actual Primary Completion Date April 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193021
Other Study ID Numbers  ICMJE PTL 0508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardiva Medical, Inc.
Study Sponsor  ICMJE Cardiva Medical, Inc.
Collaborators  ICMJE Stanford Center for Clinical Research
Investigators  ICMJE
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
PRS Account Cardiva Medical, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP