Siemens 3-D C-Arm CT of the Heart Chambers

NCT00619450 | Completed

• 1 other identifier: 07-662
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; cardiac pacing; CAT scanner

Outcome Measures

Primary Outcomes (1)

• 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.

  05/2008

Interventions

3D C-arm CT scan OTHER

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.

Also known as: DynaCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Siemens Medical Solutions: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

• 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.

  PMID: 16091535 BACKGROUND

• 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. doi: 10.1097/01.RVI.0000208984.17697.58.

  PMID: 16614155 BACKGROUND

• Lauritsch G, Boese J, Wigstrom L, Kemeth H, Fahrig R. Towards cardiac C-arm computed tomography. IEEE Trans Med Imaging. 2006 Jul;25(7):922-34. doi: 10.1109/tmi.2006.876166.

  PMID: 16827492 BACKGROUND

• 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.

  PMID: 1828490 BACKGROUND

• 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.

  PMID: 7994668 BACKGROUND

• Zellerhoff M,Scholz B, Rührschopf E-P, Brunner T. "Low Contrast 3D-reconstruction from C-arm data", Proceeding of the SPIE, Vol. 5745, 146-655.

  BACKGROUND

• 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.

  PMID: 16484404 BACKGROUND

• 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

  BACKGROUND

• Nagel H.D. Radiation Exposure in Computed Tomography. European Coordinate Committee of the Radiological and Electromedical Industries (COCIR), Hamburg, 2000.

  BACKGROUND

• Bongartz G, Golding S.J., Jurik A.G., et al. for the European Study Group. European guidelines on quality criteria for computed tomography. http://www.drs.dk/guidelines/ct/quality/mainindex.htm.

  BACKGROUND

• Banckwitz R, Strobel N, Siemens Med AX, internal communication, April 27, 2006.

  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Cummings, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)