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NCT02775565 Clinical Trial

Initial Experience With the AngioVac Venous Drainage Cannula

Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02775565
Other study ID # PV-AV400
Secondary ID
Status Completed
Phase N/A
First received April 25, 2016
Last updated December 6, 2017
Start date February 2016
Est. completion date May 2017

Study information
Verified date December 2017
Source Angiodynamics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date May 2017
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• AngioVac

Locations
Country Name City State
United States Providence St. Joseph Burbank California
United States MUSC Charleston South Carolina
United States Sanford Research Fargo North Dakota
United States UCLA Los Angeles California
United States Swedish Health Services Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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