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

Not Applicable

• Conditions: Radiation Exposure
• Interventions: Other: Mavig X-ray Protective Drapes

• Registration Number: NCT04285944
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study	Mavig X-ray Protective Drapes	-

Primary Outcome Measures

Name	Time	Method
Operator radiation dose	Immediate	Gray

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Belgium

Department of Cardiovascular Disease, University Hospitals Leuven; 🇧🇪 Leuven, Belgium