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Siemens 3-D C-Arm CT of the Heart Chambers (DynaC-Arm)

This study is currently recruiting participants.
Verified by The Cleveland Clinic, February 2008

Sponsors and Collaborators: The Cleveland Clinic
Siemens Medical Solutions
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00619450
  Purpose

The purpose of this study is to determine the optimal images of the heart structures which are used to guide AF ablation or BiVenticle and coronary vessels.


Condition Intervention
Atrial Fibrillation
Other: 3D C-arm CT scan

Genetics Home Reference related topics:   Brugada syndrome    familial atrial fibrillation    short QT syndrome   

MedlinePlus related topics:   CT Scans   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Three Dimensional C-Arm Computed Tomography of the Heart Chambers

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • To determine the optimal imaging protocol for the human heart structures which are used to guide AF ablation or biventricular pacing procedures, including the left atrium, left atrial appendage and pulmonary veins, left ventricle and coronary vessels. [ Time Frame: 05/2008 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   60
Study Start Date:   August 2007
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Other: 3D C-arm CT scan
    The patient will be given an intravenous contrast dye and then hold their breath for 15 seconds while pictures are taken. The equipment used to take the pictures is like an arch that will rotate around the body. As the arch rotates, it will collect the pictures of the heart. These pictures will then be used to compute a three-dimensional image of the heart. The physicians will then continue with the planned procedure. The three-dimensional images will be reconstructed and available for the doctor to view during the case. The images will also be examined after the procedure by the physician.
Detailed Description:

'Atrial fibrillation (AF) and ventricular fibrillation are common sustained arrhythmias. The patient will be given an intravenous contrast dye and then hold their breath for 15 seconds while pictures are taken. The equipment used to take the pictures is like an arch that will rotate around the body. As the arch rotates, it will collect the pictures of the heart. These pictures will then be used to compute a three-dimensional image of the heart. The physicians will then continue with the planned procedure. The three-dimensional images will be reconstructed and available for the doctor to view during the case. The images will also be examined after the procedure by the physician.arrythmias of the heart, AF being the most common affecting over 5 million people world wide. While drugs are a first line therapy they can have significant side effects and are often not effective long term. AF ablation and cardiac resynchronization therapy (CRT) are emerging as a viable treatment options for many patients. Both treatments require a detailed knowledge of the anatomy of the heart so that instruments can be safely and accurately navigated within the heart to treat the condition. Detailed anatomical information is limited from 2D fluoroscopy and 3D information from preoperative computed tomography (CT) or electroanatomical mapping have inherent inaccuracies. 3D rotational angiography (C-arm CT) is a technology that will use the x-ray detector system in the EP room to create a 3D image of a section of the heart, such as the left atrium, in the EP treatment room at the onset of the ablation procedure. There are several potential advantages to this imaging technique; As the 3D image is created at the start of the procedure it is a better representation of the heart's anatomy at that time than data acquired days or weeks earlier; it may eliminate the need for a preoperative CT scan for many patients; C-arm CT exposes the patient to a lower radiation dose than a regular cardiac CT scan; and, as the scan is preformed in the EP room the physician has the opportunity to perform secondary scans should he suspect anything has changed during the procedure. The purpose of the research is to determine the optimal imaging protocol for the heart structures needed in cardiac procedures such as AF and CRT. The study will vary several imaging parameters such as contrast injection site, total contrast injected, injection rate, imaging system settings and data reconstruction parameters to determine the most appropriate protocol.'

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Male or female over age of 18 years and under 250 pounds undergoing a pulmonary vein isolation or implantation of cardiac pacemaker at the Cleveland Clinic.


Criteria

Inclusion Criteria:

  • Patients undergoing EP diagnostic or therapeutic procedure
  • Age > 18 years
  • Male or Female
  • Weight < 250 lbs
  • Not pregnant - women without childbearing potential or women consenting to a pregnancy test
  • Able to hold breath for a maximum of 15 seconds
  • Sufficient kidney function to support a maximum of 200 cc of contrast in addition to whatever contrast will be given during the EP Procedure
  • Creatinine < 1.7 AND cleared by physician prior to case
  • Implantable foreign objects acceptable
  • NSR or AF
  • Patient must sign an informed consent

Exclusion Criteria:

  • Patients should not have undergone a CT or CTA scan in the 24 hours prior to this study.
  • Creatinine (GFR value) greater than 60
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619450

Contacts
Contact: Pamela Lackner     216-445-4337    
Contact: Jennifer Cummings, MD     216-444-2142    

Locations
United States, Ohio
Cleveland Clinic     Recruiting
      Cleveland, Ohio, United States, 44195
      Contact: Pamela Lackner     216-445-4337        
      Contact: Tina Sewell, RN     216-444-3270        
      Principal Investigator: Jennifer Cummings, MD            

Sponsors and Collaborators
The Cleveland Clinic
Siemens Medical Solutions

Investigators
Principal Investigator:     Jennifer Cummings, M.D.     Cleveland Clinic    
  More Information


Publications:
Benndorf G, Strother CM, Claus B, Naeini R, Morsi H, Klucznik R, Mawad ME. Angiographic CT in cerebrovascular stenting. AJNR Am J Neuroradiol. 2005 Aug;26(7):1813-8.
 
Sze DY, Strobel N, Fahrig R, Moore T, Busque S, Frisoli JK. Transjugular intrahepatic portosystemic shunt creation in a polycystic liver facilitated by hybrid cross-sectional/angiographic imaging. J Vasc Interv Radiol. 2006 Apr;17(4):711-5.
 
Lauritsch G, Boese J, Wigström L, Kemeth H, Fahrig R. Towards cardiac C-arm computed tomography. IEEE Trans Med Imaging. 2006 Jul;25(7):922-34.
 
Moe GW, Canepa-Anson R, Howard RJ, Armstrong PW. Sequential changes in atrial pressures, dimensions, and plasma atrial natriuretic factor concentrations during volume loading in hemodynamically normal human subjects. J Lab Clin Med. 1991 Jun;117(6):528-34.
 
Welikovitch L, Lafreniere G, Burggraf GW, Sanfilippo AJ. Change in atrial volume following restoration of sinus rhythm in patients with atrial fibrillation: a prospective echocardiographic study. Can J Cardiol. 1994 Dec;10(10):993-6.
 
Heran NS, Song JK, Namba K, Smith W, Niimi Y, Berenstein A. The utility of DynaCT in neuroendovascular procedures. AJNR Am J Neuroradiol. 2006 Feb;27(2):330-2.
 
Al-Ahmad A, Sandner-Porkristl D, Wigstrom L, Moore T, Boese J, Lauritsch G, Hsia H.H., Wang P.J., Fahrig R. Accuracy of Cardiac 3-D Image reconstruction of the Pulmonary Veins Using A Flat-panel C-arm CT System. Heart Rhythm Society Annual Scientific Sessions, May 2006, Boston, MA
 

Responsible Party:   Siemens Medical Solutions ( Laura Johnson, Ph.D. )
Study ID Numbers:   Dyna 3D C-Arm, 07-662
First Received:   February 7, 2008
Last Updated:   February 19, 2008
ClinicalTrials.gov Identifier:   NCT00619450
Health Authority:   United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
atrial fibrillation  
cardiac pacing  
CAT scanner  

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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