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Epicardial Access Study With Rook

NCT06388629 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-21

No results posted yet for this study

Summary

The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.

Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure.

Conditions

  • Arrythmia

Interventions

DEVICE

Rook Epicardial Access Kit

Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.

Sponsors & Collaborators

  • Circa Scientific, Inc.

    lead INDUSTRY

Principal Investigators

  • Petr Neuzil, MD · Nemocnice Na Homolce

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-17
Primary Completion
2024-10-15
Completion
2024-10-15
FDA Device
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06388629 on ClinicalTrials.gov