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Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04285944
Enrollment
1000
Registered
2020-02-26
Start date
2019-10-01
Completion date
2020-05-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Exposure

Brief summary

Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.

Interventions

OTHERMavig X-ray Protective Drapes

Mavig X-ray Protective Drapes®

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention. 2. The coronary angiogram/cardiac catheterization/PCI procedure is elective. 3. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

Exclusion criteria

1\. The procedure is an emergency and/or the patient is unstable. -

Design outcomes

Primary

MeasureTime frameDescription
Operator radiation doseImmediateGray

Countries

Belgium

Contacts

Primary ContactSabine Van Roey
sabine.vanroey@uzleuven.be003216342465
Backup ContactKeir Mccutcheon
keir.mccutcheon@uzleuven.be+32468312267

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026