ATTENUATE (rAdpad proTecTion drapE iN redUcing rAdiaTion Exposure) Trial

The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected to be enrolled across 1 site. The proximal operator cohort is expected to include a few interventional cardiologist attending physicians, interventional cardiology fellows, cardiovascular disease fellows and physician assistants performing multiple cases each, which in total would amount to 1,000 cases performed by 100 proximal operators. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.

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Key information

Conditions

Radiation Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Hospital - Long Island

New York, 11501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Employees):

Proximal operator of a cardiac catheterization procedure as defined by the individual performing the procedure closest to the source of radiation. This may be either physician assistants of the CCL, fellows of cardiovascular disease, interventional cardiology fellows or attending interventional cardiologists at NYU Langone Hospital - Long Island.
Age ≥18 years
Willing and able to consent.

Inclusion criteria

(Patient Cases):

Cardiac catheterization procedure at NYU Langone Hospital - Long Island.
Age ≥18 years of the patient undergoing cardiac catheterization.

Exclusion criteria

(Employees):

Anyone unable or unwilling to give informed consent.
Anyone pregnant or breastfeeding.
A proximal operator performing a cardiac catheterization procedure where there are not located on the right-side of the patient and/or behind the radiation shield.
Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized

Exclusion criteria

(Patient Cases):

There are no specific exclusion criteria that pertain exclusively to the cardiac catheterization procedure.

Treatment and study plan

RADPAD

Device

The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and Digital subtraction angiography (DSA) settings.

Primary outcomes

Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator

Time frame: From start of each procedure until end of each procedure (up to 1 day)

This is a continuous variable which will be analyzed statistically using the student's t-test.
OE/DAP (uSv/mGy*cm2) of the Proximal Operator

Time frame: From start of each procedure until end of each procedure (up to 1 day)

This is a continuous variable which will be analyzed statistically using the student's t-test.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 31, 2024
Registry last updated: Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed