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Data Collection During CT for Axial Flow VADs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427739
First Posted: January 29, 2007
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Subha Raman, The Ohio State University
  Purpose

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).


Condition Intervention
Heart Failure Procedure: Cardiac CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Data Collection During Computerized Tomography (CT) to Determine Accurate Flow Rates for Axial Flow Ventricular Assist Device (VAD) Patients

Resource links provided by NLM:


Further study details as provided by Subha Raman, The Ohio State University:

Primary Outcome Measures:
  • data collection to help determine better clinical evaluation [ Time Frame: ongoing ]

Enrollment: 9
Study Start Date: June 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CCT exam Procedure: Cardiac CT
64 slice spiral computerized tomography

Detailed Description:
Description as listed in Summary. The hemodynamic data collected along with pump parameters may help determine more accurate flow rates specific to each patient.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with implanted left ventricular assist devices referred for CT scans
Criteria

Inclusion Criteria:

  • Signed Informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427739


Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Subha Raman
Investigators
Principal Investigator: Benjamin Sun, MD Ohio State University, Division of Cardiothoracic Surgery
  More Information

Responsible Party: Subha Raman, Professor of Medicine, The Ohio State University
ClinicalTrials.gov Identifier: NCT00427739     History of Changes
Other Study ID Numbers: 2005H0200
First Submitted: January 25, 2007
First Posted: January 29, 2007
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Subha Raman, The Ohio State University:
Axial Flow Ventricular Assist Device
Cardiac CT
Stage IV heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases