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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01165593
Other study ID # H10-01337
Secondary ID
Status Completed
Phase N/A
First received July 16, 2010
Last updated April 15, 2015
Start date November 2010
Est. completion date October 2013

Study information

Verified date April 2015
Source Kardium Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.


Description:

Correct device design depends on getting good information about the shape and size of the different parts of the heart. Measurements from computed tomography images of hearts will be studied. By looking at measurements from a wide range of patients, an understanding of the differences in the size and shape of the heart chambers will be gained.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.

Exclusion Criteria:

- Patients who have not received cardiac CT imaging as part or normal care.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
There is no intervention that is a part of this study.
There is no intervention that is a part of this study. Imaging data is gathered as part of normal care.

Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Kardium Inc. St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary LA size measurements 3 months No
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