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

Atrial Fibrillation Clinical Trial

— DynaC-Arm  

Official title:

Three Dimensional C-Arm Computed Tomography of the Heart Chambers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619450
• Other study ID #: 07-662
• Status: Completed
• Phase: N/A
• First received: February 7, 2008
• Last updated: January 31, 2017
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.'

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

References & Publications (11)

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

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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