# PeriScope: A Novel Videoscope and Toolkit to Enable Fluoro-free Pericardial Access for Epicardial Ablation

> **NIH NIH R41** · PERICOR, LLC · 2024 · $295,922

## Abstract

Project Summary
 Safe pericardial access is an essential and challenging first step for epicardial procedures
such as epicardial ablation. Over 300,000 ablation procedures are performed annually in the
United States alone, and 20% of patients suffering from ventricular tachycardia will need a
pericardial access procedure for epicardial ablation of the heart. The current standard of care for
these patients is fluoroscopically guided pericardial access. Unfortunately, tissues layers and key
cardiac structures are not easily visible under fluoroscopy leading to accidental needle stick with
ventricular puncture and excessive pericardial bleeding in 10% of cases. In low volume centers,
complications are even more common, and cardiothoracic surgeons are on-site to perform
emergency surgery if necessary. There is a clear unmet clinical need for a device to enable safe,
consistent, pericardial access as an alternative to fluoroscopic guidance.
The goal of this Phase I STTR project is to demonstrate superior pericardial access with resulting
epicardial mapping and ablation using color imaging as compared to fluoroscopically guided
procedures (standard of care). To achieve this goal, we will complete the following specific aims:
Aim 1: Develop the next generation PeriScope device and demonstrate usability and compatibility
with fluoro-free epicardial mapping. We will 1) reduce PeriScope’s access needle to 18G while
maintaining high image resolution image quality and 2) develop a color imaging introducer to
visualize ablation catheters entering the pericardial space. These innovations will enable a
fluoroless pericardial access procedure which will be validated in a 24 subject usability study.
Aim 2: Demonstrate improved pericardial access in an acute in vivo study. We will compare
pericardial access with resulting epicardial mapping and ablation using the fluoro-free PeriScope
tool to fluoroscopically guided procedures. We will compare procedure times and safety as
measured by 1) number of pericardial access attempts, 2) severity of complications, 3) number
of heart perforations, and 4) resulting volume of pericardial bleeding.
 This research could have a transformative impact in changing current clinical practice by
converting a challenging fluoroscopically guided procedure to a more intuitive and safe color
imaging technique. While this study focuses on pericardial access for epicardial ablation, the
technique could also be used to deliver epicardial pacing and defibrillation therapies for infants
and children with congenital heart disease, as well as benefit thousands of adult patients who
have indications for cardiac resynchronization therapy but do not achieve successful implantation
due to lack of transvenous access or adequate coronary sinus venous tributaries.

## Key facts

- **NIH application ID:** 10920941
- **Project number:** 1R41HL174307-01
- **Recipient organization:** PERICOR, LLC
- **Principal Investigator:** CHARLES I BERUL
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $295,922
- **Award type:** 1
- **Project period:** 2024-05-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10920941

## Citation

> US National Institutes of Health, RePORTER application 10920941, PeriScope: A Novel Videoscope and Toolkit to Enable Fluoro-free Pericardial Access for Epicardial Ablation (1R41HL174307-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10920941. Licensed CC0.

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