Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (REDEFINE)

Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation (REDEFINE): A Prospective, Randomized Evaluation of the ControlRad System to Reduce Radiation Exposure During Cardiac Catheterization and Electrophysiology (EP) Procedures.

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Catheterization; Radiation Exposure
• Intervention / Treatment: Radiation: ControlRad System; Radiation: Without ControlRad System

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 reduce radiation exposure without compromising image quality in the region of interest and overall workflow during cardiac catheterization and electrophysiology (EP) implant procedures. Enrollment will be limited to 40 cardiac catheterization, and 30 pacemaker and/or ICD procedures. All patients presenting to Beaumont Hospital Royal Oak who are scheduled for cardiac catheterization with coronary angiography and electrophysiology implant in Cath Lab 5 where device is installed will be considered for inclusion in the study. Physicians and staff (20 fellows; 35 attending physicians; and 56 Cath-lab staff,including Nurse/Anesthesia team) will be invited to participate in the study. For each procedure, 3 staff members will be study subjects: a) the primary operator, b) the secondary operator, c) the nurse/tech and or Anesthetist who circulates in the room. Different operators and staff may participate in each case depending on cath-lab scheduling. The Primary operator is the physician who usually stands nearest to the C-arm. In most cases in Beaumont this is a Cardiology Fellow in cardiac catheterization cases and Attending Physician for the EP cases. The Secondary operator is the physician who typically stands to the right of the primary operator and in most cases is the attending cardiologist or scrub assistant (nurse/technician). The Nurse or Anesthesia team typically circulates in the room and is responsible for monitoring the patient, administering medications and obtaining equipment for the procedure.

Two methods will be used to measure radiation dose during the catheterization procedure. The Real-time Dosimeter Badge (RaySafe) and the Landauer Luxel Aluminium Oxide Dosimeter Badges. Cardiac Catheterization and electrophysiology implant procedures will be performed according to standard guidelines.

Participants will be randomized 1:1 to either cardiac catheterization without ControlRad or cardiac catheterization with the ControlRad system. The same 1:1 randomization process will be applied to the EP patient population. Participants will be blinded to the randomization.

Once procedure is done,participation also ended and the badges will be removed by the Radiation Safety Officer or research coordinator.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital - Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ControlRad System; Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5	Radiation: ControlRad System; Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Active Comparator: Without ControlRad System; Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5.	Radiation: Without ControlRad System; Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization	Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization	Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Primary Operator, EP Procedure (Luxel)	Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.	During each EP implant procedure, an average of 90 minutes
Radiation Dose to Primary Operator, EP Procedure (RaySafe)	Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.	During each EP implant procedure, an average of 90 minutes duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)	Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization	Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)	Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)	Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Patient, Cardiac Catheterization	Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy*m^2.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose in Cath Lab Room #5, Cardiac Catheterization	Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (RaySafe)	Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.	During each EP implant procedure, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (Luxel)	Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)	Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.	During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)	Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each EP implant procedure, an average of 90 minutes
Radiation Dose to Patient, EP Procedure	Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy*m^2)	During each EP implant procedure, an average of 30-45 minutes of active radiation
Radiation Dose in Cath Lab Room #5, EP Procedure	Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.	During each EP implant procedure, an average of 90 minutes

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Simon Dixon, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): December 3, 2021
• Study Completion (Actual): December 3, 2021

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Catheterization; Radiation Exposure; ControlRad System; Fluoroscopic x-ray
• Other Study ID Numbers: 2019-174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes