Status:
UNKNOWN
Evaluation of Exposure Reduction Using Region-of-Interest Fluoroscopy (X-ray Fovea Imaging) in Cardiac Interventions
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
General Electric
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of the proposed study is to compare the exposure dose and diagnostic performance of region-of-interest fluoroscopy compared to standard fluoroscopy in patients and interventionists during card...
Detailed Description
X-ray catheterization is used to guide minimally invasive procedures including percutaneous coronary interventions (PCIs), involving diffuse and multiple vessel disease and total chronic occlusion as ...
Eligibility Criteria
Inclusion
- The subject is greater than 18 years of age.
- The subject is currently planned for conventional cardiac interventional procedures (i.e. catheterization, percutaneous coronary intervention (PCI), electrophysiology (EP) ablations and procedures) as specified by his/her physician.
- The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
Exclusion
- The subject is pregnant or trying to become pregnant.
- The subject requires urgent/emergent cardiac catheterization, PCI, and/or EP procedures as per treating physician.
- The subject has been previously included in the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00817115
Start Date
February 1 2009
Last Update
August 7 2009
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5