N/A
Completed N=170
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
Cardiac Catheterization · Radiation Exposure
Source: ClinicalTrials.gov NCT04404257 ↗
Enrolled (actual)
170
Serious AEs
0.6%
Results posted
Jan 2023
Primary outcomePrimary: Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization — 18; 39 microsievert
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 patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization |
18; 39 | — |
| PRIMARY Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization |
18; 41 | — |
| PRIMARY Radiation Dose to Primary Operator, EP Procedure (Luxel) |
21.7; 58.1 | — |
| PRIMARY Radiation Dose to Primary Operator, EP Procedure (RaySafe) |
25; 61 | — |
| SECONDARY Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe) |
12; 21 | — |
| SECONDARY Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization |
13; 26 | — |
| SECONDARY Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe) |
NA; NA | — |
| SECONDARY Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel) |
NA; NA | — |
| SECONDARY Radiation Dose to Patient, Cardiac Catheterization |
2276; 3487 | — |
| SECONDARY Radiation Dose in Cath Lab Room #5, Cardiac Catheterization |
15; 25 | — |
| SECONDARY Radiation Dose to Secondary Operator, EP Procedure (RaySafe) |
3; 5 | — |
| SECONDARY Radiation Dose to Secondary Operator, EP Procedure (Luxel) |
1.6; 9 | — |
| SECONDARY Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe) |
0; 2 | — |
| SECONDARY Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel) |
0; 3.8 | — |
| SECONDARY Radiation Dose to Patient, EP Procedure |
43.7; 72.5 | — |
| SECONDARY Radiation Dose in Cath Lab Room #5, EP Procedure |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- - 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 Criteria
- - 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
Data sourced from ClinicalTrials.gov (NCT04404257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.