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

ClinicalTrials.gov ID

NCT04285944

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,000Estimated

Last Update Posted

Mar 4, 2020Actual

Start Date

Oct 1, 2019Actual

Primary Completion Date

May 31, 2020Estimated

Completion Date

May 31, 2020Estimated

Official Title

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

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®.

• Radiation Exposure

• Mavig X-ray Protective Drapes

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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. -

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

sabine.vanroey@uzleuven.be+32 16 34 24 66

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