Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation

Completed · Not applicable

Conditions studied: Cardiac Catheterization, Radiation Exposure

In brief

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 patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.

Key facts

Study ID

NCT04404257

Run by

Corewell Health East

People needed

170

Starts

2020-11-05

Expected to finish

2021-12-03

Last updated by the study team

2023-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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

You may not qualify if…

• - 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

Where it is running

• Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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