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

NCT03193021 | Completed Results DMC FDA Device

• 1 other identifier: PTL 0508
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 13

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.

Conditions

Surgical Wound

Keywords

vessel closure; venous access site; femoral venotomy; medium bore; multiple access sites

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event

  30 +/- 7 days post-procedure

• Time to Discharge Eligibility (TTDE)

  Prior to hospital discharge, usually within 24 hours

• Time to Hemostasis (TTH)

  Post-procedure, usually within 3 hours

• Time to Discharge (TTD)

  Prior to hospital discharge, usually within 24 hours

• Time to Closure Eligibility (TTCE)

  Post-procedure, usually within 6 hours

Study Arms (2)

Cardiva Mid-Bore VVCS

EXPERIMENTAL

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

Manual Compression

ACTIVE COMPARATOR

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

Interventions

Cardiva Mid-Bore VVCS DEVICE

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.

Cardiva Mid-Bore VVCS

Manual compression OTHER

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.

Manual Compression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiva Medical, Inc.: lead

Study Sites (13)

Alaska Heart & Vascular

Anchorage, Alaska, 99508, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Stanford University Hospital

Stanford, California, 94305, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Intermountain Health Care

Murray, Utah, 84107, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 31971899 DERIVED

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Terry Alverson, Director of Regulatory and Clinical
• Organization: Cardiva Medical

Terry_Alverson@cardivamedical.com

650-207-0563

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

• Steve Compton, MD

  Alaska Heart Institute

  PRINCIPAL INVESTIGATOR

• Mintu Turakhia, MD

  Stanford Center for Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Safety Monitoring Committee will adjudicate endpoint events, blinded to treatment assignment when possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: September 20, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: March 10, 2023
• Results First Posted: February 5, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)