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

NCT ID: NCT03193021

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2018-04-13

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.

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.

Conditions

Surgical Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cardiva Mid-Bore VVCS

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

Group Type: EXPERIMENTAL

Cardiva Mid-Bore VVCS

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Manual compression

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiva Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Steve Compton, MD

Role: PRINCIPAL_INVESTIGATOR

Alaska Heart Institute

Mintu Turakhia, MD

Role: STUDY_DIRECTOR

Stanford Center for Clinical Research

Locations

Alaska Heart & Vascular

Anchorage, Alaska, United States

Mercy General Hospital

Sacramento, California, United States

Stanford University Hospital

Stanford, California, United States

Medstar Washington Hospital Center

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

Emory St. Joseph's Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

Centennial Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Intermountain Health Care

Murray, Utah, United States

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31971899 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

PTL 0508

Identifier Type: -

Identifier Source: org_study_id