Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases

This study has been completed.
Sponsor:
Collaborator:
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
Kardium Inc.
ClinicalTrials.gov Identifier:
NCT01165593
First received: July 16, 2010
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention
Atrial Fibrillation
Other: There is no intervention that is a part of this study.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases

Resource links provided by NLM:


Further study details as provided by Kardium Inc.:

Primary Outcome Measures:
  • LA size measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: November 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with atrial fibrillation
Patients with atrial fibrillation who have received a cardiac CT scan as part of normal care prior to catheter-based treatment of atrial fibrillation.
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with atrial fibrillation who are deemed suitable for treatment of atrial fibrillation by catheter-based ablation.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165593

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
Kardium Inc.
St. Paul's Hospital, Canada
Investigators
Principal Investigator: John A. Yeung-Lai-Wah, MD St' Paul's Hospital Electrophysiology (Providence Health Care)
  More Information

No publications provided

Responsible Party: Kardium Inc.
ClinicalTrials.gov Identifier: NCT01165593     History of Changes
Other Study ID Numbers: H10-01337
Study First Received: July 16, 2010
Last Updated: April 15, 2015
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2015