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

Primary Purpose

Surgical Wound

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiva Mid-Bore VVCS
Manual compression
Sponsored by
Cardiva Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Heart & Vascular
  • Mercy General Hospital
  • Stanford University Hospital
  • Medstar Washington Hospital Center
  • Emory St. Joseph's Hospital
  • University of Chicago
  • Advocate Christ Medical Center
  • The Valley Hospital
  • Mount Sinai Hospital
  • Centennial Medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • Intermountain Health Care
  • University of Utah Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiva Mid-Bore VVCS

Manual Compression

Arm Description

Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.

Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.
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
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)
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
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
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)

Full Information

First Posted
June 16, 2017
Last Updated
February 10, 2023
Sponsor
Cardiva Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03193021
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
April 13, 2018 (Actual)
Study Completion Date
April 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiva Medical, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
vessel closure, venous access site, femoral venotomy, medium bore, multiple access sites

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Data Safety Monitoring Committee will adjudicate endpoint events, blinded to treatment assignment when possible
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiva Mid-Bore VVCS
Arm Type
Experimental
Arm Description
Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case.
Arm Title
Manual Compression
Arm Type
Active Comparator
Arm Description
Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case.
Intervention Type
Device
Intervention Name(s)
Cardiva Mid-Bore VVCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual compression
Intervention Description
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 Measure Information:
Title
Time to Ambulation (TTA)
Description
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.
Time Frame
Post-procedure, usually within 6 hours
Title
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Description
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.
Time Frame
30 +/- 7 days post-procedure
Secondary Outcome Measure Information:
Title
Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Description
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.
Time Frame
30 +/- 7 days post-procedure
Title
Time to Discharge Eligibility (TTDE)
Description
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 Frame
Prior to hospital discharge, usually within 24 hours
Title
Time to Hemostasis (TTH)
Description
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 Frame
Post-procedure, usually within 3 hours
Title
Time to Discharge (TTD)
Description
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 Frame
Prior to hospital discharge, usually within 24 hours
Title
Time to Closure Eligibility (TTCE)
Description
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)
Time Frame
Post-procedure, usually within 6 hours
Title
Total Post-Procedure Time (TPPT)
Description
Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate
Time Frame
Post-procedure, usually within 6 hours
Title
Number of Participants With Procedure Success
Description
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Time Frame
30 +/- 7 days post-procedure
Title
Number of Access Sites With Device Success
Description
Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)
Time Frame
Procedural, usually within 15 minutes of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Compton, MD
Organizational Affiliation
Alaska Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mintu Turakhia, MD
Organizational Affiliation
Stanford Center for Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Heart & Vascular
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Intermountain Health Care
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31971899
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.
Results Reference
derived

Learn more about this trial

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

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