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Rook Epicardial Access Device Study

NCT03427333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-03-29

No results posted yet for this study

Summary

The purpose of this study is to confirm the efficacy and safety of the Talon Surgical Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.

Conditions

  • Ventricular Tachycardia
  • Arrythmia

Interventions

DEVICE

The Rook® Epicardial Access Kit

Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.

Sponsors & Collaborators

  • Talon Surgical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2018-06-30
Completion
2019-02-25
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 NCT03427333 on ClinicalTrials.gov