NCT02775565

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

April 25, 2016

Last Update Submit

December 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

AngioVacDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Providence St. Joseph

Burbank, California, 91505, United States

Location

UCLA

Los Angeles, California, 90024, United States

Location

Sanford Research

Fargo, North Dakota, 58122, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 17, 2016

Study Start

February 1, 2016

Primary Completion

September 1, 2016

Study Completion

May 1, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations