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AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)

NCT03573206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

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 at the completion of catheter-based procedures performed through 6-12 Fr introducer sheath, while allowing for one or more of the following: elimination of the Foley catheter, elimination of protamine, or allowing same (calendar) day discharge for the appropriate patient population.

Conditions

  • Surgical Wound

Interventions

DEVICE

Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)

The device will be used to close all femoral venous access sites at the end of the case.

Sponsors & Collaborators

  • Cardiva Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Amin M Al-Ahmad, MD · Texas Cardiac Arrhythmia Research Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2019-01-14
Completion
2019-03-31
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 NCT03573206 on ClinicalTrials.gov