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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure
• Intervention / Treatment: Device: RADPAD

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11501
      • NYU Langone Hospital - Long Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RADPAD; Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.	Device: RADPAD; 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.
No Intervention: No RADPAD; Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator	This is a continuous variable which will be analyzed statistically using the student's t-test.	From start of each procedure until end of each procedure (up to 1 day)
OE/DAP (uSv/mGy*cm2) of the Proximal Operator	This is a continuous variable which will be analyzed statistically using the student's t-test.	From start of each procedure until end of each procedure (up to 1 day)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Giorgio A. Medranda, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-01408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: giorgio.medranda@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to giorgio.medranda@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes