Clinical trial NCT04404257: Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Catheterization
Radiation Exposure
Keywords: ControlRad System
Cardiac Catheterization
Radiation Exposure
Fluoroscopic x-ray
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 like a flip of a coin, to receive either cardiac catheterization and or electrophysiology implant procedures without ControlRad system or cardiac catheterization and or electrophysiology (EP) implant procedures with the ControlRad system.
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Primary Operator, EP Procedure (Luxel)
timeFrame: During each EP implant procedure, an average of 90 minutes
measure: Radiation Dose to Primary Operator, EP Procedure (RaySafe)
timeFrame: During each EP implant procedure, an average of 90 minutes duration
Secondary outcomes:
measure: Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Patient, Cardiac Catheterization
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose in Cath Lab Room #5, Cardiac Catheterization
timeFrame: During each cardiac catheterization, an average of 90 minutes
measure: Radiation Dose to Secondary Operator, EP Procedure (RaySafe)
timeFrame: During each EP implant procedure, an average of 90 minutes
measure: Radiation Dose to Secondary Operator, EP Procedure (Luxel)
timeFrame: During each EP implant procedure, an average of 90 minutes
measure: Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)
timeFrame: During each EP implant procedure, an average of 90 minutes
measure: Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)
timeFrame: During each EP implant procedure, an average of 90 minutes
measure: Radiation Dose to Patient, EP Procedure
timeFrame: During each EP implant procedure, an average of 30-45 minutes of active radiation
measure: Radiation Dose in Cath Lab Room #5, EP Procedure
timeFrame: During each EP implant procedure, an average of 90 minutes
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital - Royal Oak
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Simon Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References: