NCT03193021

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Cardiva Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-20
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2017-06-20
• Last updated: 2023-03-10
• Results posted: 2020-02-05

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study