NCT00427739

Brief Summary

At present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (VADS). If a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and determine a more accurate rate per specific patient. Data Analyzed with following results: Article in Press for Cardiopulmonary Support and Physiology, results state "Pairwise comparison of calculated output from left ventricular assist devices is feasible using first pass dynamic computed tomography test bolus technique versus thermodilution output measurements yielded good agreement (P=.03). The output calculated using dynamic CT underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence interval 0.66-0.94).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

January 25, 2007

Last Update Submit

March 29, 2017

Conditions

Heart Failure

Keywords

Axial Flow Ventricular Assist DeviceCardiac CTStage IV heart failure

Outcome Measures

Primary Outcomes (1)

  • data collection to help determine better clinical evaluation

    ongoing

Study Arms (1)

CCT exam

Procedure: Cardiac CT

Interventions

Cardiac CTPROCEDURE

64 slice spiral computerized tomography

CCT exam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with implanted left ventricular assist devices referred for CT scans

You may qualify if:

  • Signed Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Benjamin Sun, MD

    Ohio State University, Division of Cardiothoracic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

June 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

US(1)