Atrial FibrillationNCT01165593
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
An observational study of Atrial Fibrillation, run by Kardium Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with atrial fibrillation who are deemed suitable for treatment of atrial fibrillation by catheter-based ablation.
Who may be able to join
- Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.
Who cannot join
- Patients who have not received cardiac CT imaging as part or normal care.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- There is no intervention that is a part of this study.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention that is a part of this study.Other
There is no intervention that is a part of this study. Imaging data is gathered as part of normal care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: There is no intervention that is a part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LA size measurements
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Paul's Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- John A. Yeung-Lai-Wah, MD, Principal investigator, St' Paul's Hospital Electrophysiology (Providence Health Care)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165593
- Sponsor's protocol ID
- H10-01337
- Status last verified
- Apr 2015
- First submitted
- 16 Jul 2010
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
- ClinicalTrials.gov ID
- NCT01165593
- Acronym / sponsor ID
- H10-01337
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Paul's Hospital, Canada
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information about the size and shape of patients' hearts in order to design a device.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with atrial fibrillation | – | Other: There is no intervention that is a part of this study.Patients with atrial fibrillation who have received a cardiac CT scan as part of normal care prior to catheter-based treatment of atrial fibrillation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with atrial fibrillation who are deemed suitable for treatment of atrial fibrillation by catheter-based ablation.
Key inclusion criteria (1 listed)
- Patients deemed suitable for treatment of atrial fibrillation by catheter-based ablation who have received cardiac CT imaging as part of normal care.
Key exclusion criteria (1 listed)
- Patients who have not received cardiac CT imaging as part or normal care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with atrial fibrillation |
Primary outcome
LA size measurements
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A. Yeung-Lai-Wah, MD principal investigator
St' Paul's Hospital Electrophysiology (Providence Health Care)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Kardium Inc. at 1 site in Canada.
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 1 inclusion and 1 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 16 Apr 2015. 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 Canada. 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?
LA size measurements (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2015.