Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation

NCT04404257 | Completed Results FDA Device

• 1 other identifier: 2019-174
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Catheterization; Radiation Exposure

Keywords

ControlRad System; Cardiac Catheterization; Radiation Exposure; Fluoroscopic x-ray

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)

  During each cardiac catheterization, an average of 90 minutes

• Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization

  During each cardiac catheterization, an average of 90 minutes

• Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)

  During each cardiac catheterization, an average of 90 minutes

• Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)

  During each cardiac catheterization, an average of 90 minutes

• Radiation Dose to Patient, Cardiac Catheterization

  During each cardiac catheterization, an average of 90 minutes

Study Arms (2)

ControlRad System

EXPERIMENTAL

Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5

Radiation: ControlRad System

Without ControlRad System

ACTIVE COMPARATOR

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

Interventions

ControlRad System RADIATION

Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.

ControlRad System

Without ControlRad System RADIATION

Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.

Without ControlRad System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Results Point of Contact

• Title: Dr. Simon Dixon, MD
• Organization: William Beaumont Hospitals

simon.dixon@beaumont.edu

248-898-4198

Study Officials

• Simon Dixon, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to the arm assigned to; but the investigators, cath lab operators and staff will be informed of the randomized assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: May 27, 2020
• Study Start: November 5, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: January 11, 2023
• Results First Posted: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)