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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
History of Changes
  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: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • data collection to help determine better clinical evaluation [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

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)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed consent
  • HeartMate II VAD
  • Patient requires a right heart cath
  • No contraindication to CT scan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427739

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

No publications provided

Responsible Party: Benjamin Sun, M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT00427739     History of Changes
Other Study ID Numbers: 2005H0200
Study First Received: January 25, 2007
Last Updated: April 9, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013