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Atrial FibrillationDynaC-ArmNCT00619450

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

An observational study of Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
3D C-arm CT scan
Type of treatment
Injection or infusion
How many people
16 participants
Where
1 siteUnited States
Study dates
Aug 2007to Sep 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Three Dimensional C-Arm Computed Tomography of the Heart Chambers

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.

Read the 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.'

Being tested
3D C-arm CT scan
Keywords
atrial fibrillation, cardiac pacing, CAT scanner
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D C-arm CT scanOther

    Also called DynaCT

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 05/2008

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00619450
Sponsor's protocol ID
07-662
Acronym
DynaC-Arm
Status last verified
Jan 2017
First submitted
7 Feb 2008
Last updated
1 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 16091535

  • 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.

    PubMed 16614155

  • 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.

    PubMed 16827492

  • 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.

    PubMed 1828490

  • 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.

    PubMed 7994668

  • 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.

  • 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.

    PubMed 16484404

  • 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

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

  • 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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00619450, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.

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