Data Collection During CT for Axial Flow VADs

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00427739
First received: January 25, 2007
Last updated: April 9, 2010
Last verified: April 2010

January 25, 2007
April 9, 2010
June 2006
February 2009   (final data collection date for primary outcome measure)
data collection to help determine better clinical evaluation [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
Flow, Power, Volts, Speed, Pulsatile Index, Cardiac Output, PA pressures, Heartrate and Central Venous Pressure
Complete list of historical versions of study NCT00427739 on ClinicalTrials.gov Archive Site
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Data Collection During CT for Axial Flow VADs
Pilot Study of Data Collection During Computerized Tomography (CT) to Determine Accurate Flow Rates for Axial Flow Ventricular Assist Device (VAD) Patients

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).

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

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure
Procedure: Cardiac CT
64 slice spiral computerized tomography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed Informed consent
  • HeartMate II VAD
  • Patient requires a right heart cath
  • No contraindication to CT scan
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00427739
2005H0200
No
Benjamin Sun, M.D., The Ohio State University
Ohio State University
Not Provided
Principal Investigator: Benjamin Sun, MD Ohio State University, Division of Cardiothoracic Surgery
Ohio State University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP