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

Radiation Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285944
• Other study ID #: S62469
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: March 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Sabine Van Roey
• Phone: 003216342465
• Email: sabine.vanroey[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

Other:
• Mavig X-ray Protective Drapes
Mavig X-ray Protective Drapes®

Locations

Country	Name	City	State
Belgium	Department of Cardiovascular Disease, University Hospitals Leuven	Leuven
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operator radiation dose	Gray	Immediate