Data Collection During CT for Axial Flow VADs - Full Text View

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.

Condition	Intervention
Heart Failure	Procedure: Cardiac CT

MedlinePlus related topics:

CT Scans Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Pilot Study of Data Collection During Computerized Tomography (CT) to Determine Accurate Flow Rates for Axial Flow Ventricular Assist Device (VAD) Patients

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 ]

Estimated Enrollment:	10
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts


Contact: Tamara L Yanssens, BSN	614-293-8173	yanssens.1@osu.edu

Contact: Sherri Wissman, BSN	614-293-4473	sherri.wissman@osumc.edu

Locations


United States, Ohio
	The Ohio State University Medical Center	Recruiting
	Columbus, Ohio, United States, 43210
	Principal Investigator: Sun Benjamin, MD

Sponsors and Collaborators

Ohio State University

Investigators


Principal Investigator:	Benjamin Sun, MD	Ohio State University, Division of Cardiothoracic Surgery

More Information

Responsible Party:	The Ohio State University ( Benjamin Sun, M.D. )
Study ID Numbers:	2005H0200
First Received:	January 25, 2007
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00427739
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Axial Flow Ventricular Assist Device

Cardiac CT

Stage IV heart failure

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00427739