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

NCT03193021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-03-10

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Cardiva Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

  • Steve Compton, MD · Alaska Heart Institute

  • Mintu Turakhia, MD · Stanford Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2018-04-13
Completion
2018-04-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193021 on ClinicalTrials.gov