Initial Experience With the AngioVac Venous Drainage Cannula

Initial Experience With the AngioVac Venous Drainage Cannula and Cardiopulmonary Bypass Circuit: A Retrospective, Multi-Center Chart Review

This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.

Study Overview

• Status: Completed
• Conditions: Heart Disease
• Intervention / Treatment: Device: AngioVac

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Providence St. Joseph
    • Los Angeles, California, United States, 90024
      • UCLA
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.

Description

Inclusion Criteria:

• Consecutive patients treated at each study site between February 1, 2013 and February 28, 2015 will be included.

Exclusion Criteria:

• Patients treated with the AngioVac venous drainage system outside of those dates.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detailing early clinical experience with the AngioVac Venous Drainage Cannula	Experience and success is determined immediately after the procedure is completed. No subject follow up data is collected and retrospective data will be reviewed.

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: PV-AV400