Status:
COMPLETED
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
Lead Sponsor:
Corewell Health East
Conditions:
Cardiac Catheterization
Radiation Exposure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether the ControlRad system device when installed in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and to the patien...
Detailed Description
This is a Prospective, randomized (like a "flip of a coin") single center study evaluating the ControlRad system device when installed - retrofitted on existing C-arms for fluoroscopy (x-ray) will red...
Eligibility Criteria
Inclusion
- \- Patient
- Scheduled to undergo left heart catheterization with angiography, and/or percutaneous coronary intervention
- Scheduled to undergo pacemaker or ICD implant
- EP device upgrade
- Able to provide written informed consent prior to the procedure
- Age ≥18 years
- Physicians and Staff o Able to provide consent for the study
Exclusion
- \- Patient
- Cardiogenic shock
- Reason for cath procedure is pericardiocentesis
- Subcutaneous ICDs
- Lead revisions
- Inability to provide informed consent
- Pregnant
- Physicians and Staff
- Those who are not willing to participate in the study
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2021
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04404257
Start Date
November 5 2020
End Date
December 3 2021
Last Update
January 11 2023
Active Locations (1)
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1
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073