Cardiac CatheterizationREDEFINENCT04404257
Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation
A study of Cardiac Catheterization and Radiation Exposure, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Catheterization, Radiation Exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 3 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - Patient
- Cardiogenic shock
- Reason for cath procedure is pericardiocentesis
- Subcutaneous ICDs
- Lead revisions
- Inability to provide informed consent
Show all 9Show fewer
- Pregnant
- Physicians and Staff
- Those who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
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.
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.
Read the 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.
- Conditions
- Cardiac Catheterization, Radiation Exposure
- Being tested
- ControlRad System, Without ControlRad System
- Keywords
- ControlRad System, Cardiac Catheterization, Radiation Exposure, Fluoroscopic x-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlRad SystemRadiation
Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Without ControlRad SystemRadiation
Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
| Study group | Role | What they receive |
|---|---|---|
| ControlRad System | Experimental | Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 Receives: 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. Receives: Radiation: Without ControlRad System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During each EP implant procedure, an average of 90 minutes duration
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: During each EP implant procedure, an average of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start5 Nov 2020
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Dixon, MD, Corewell Health East
- Investigators
- Simon Dixon, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404257
- Sponsor's protocol ID
- 2019-174
- Acronym
- REDEFINE
- Status last verified
- Dec 2022
- First submitted
- 8 Apr 2020
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04404257
- Acronym / sponsor ID
- REDEFINE / 2019-174
- Conditions
- Cardiac Catheterization, Radiation Exposure
- Keywords
- ControlRad System, Cardiac Catheterization, Radiation Exposure, Fluoroscopic x-ray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ControlRad System | Experimental | Radiation: ControlRad SystemParticipant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 |
| Without ControlRad System | Active comparator | Radiation: Without ControlRad SystemParticipant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - Patient
- Physicians and Staff o Able to provide consent for the study
Key exclusion criteria (9 listed)
- - Patient
- Physicians and Staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlRad SystemCardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5. | Radiation | ControlRad System |
| Without ControlRad SystemCardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device. | Radiation | Without ControlRad System |
Primary outcome
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
Time frame: During each cardiac catheterization, an average of 90 minutes
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.
Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization
Time frame: During each cardiac catheterization, an average of 90 minutes
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.
Radiation Dose to Primary Operator, EP Procedure (Luxel)
Time frame: During each EP implant procedure, an average of 90 minutes
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.
Radiation Dose to Primary Operator, EP Procedure (RaySafe)
Time frame: During each EP implant procedure, an average of 90 minutes duration
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.
12 secondary outcomes
Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Patient, Cardiac Catheterization
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose in Cath Lab Room #5, Cardiac Catheterization
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (RaySafe)
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (Luxel)
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Patient, EP Procedure
Time frame: During each EP implant procedure, an average of 30-45 minutes of active radiation
Radiation Dose in Cath Lab Room #5, EP Procedure
Time frame: During each EP implant procedure, an average of 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Dixon, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiac Catheterization and Radiation Exposure, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization (time frame: During each cardiac catheterization, an average of 90 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 26 Oct 2026.