RecruitingNot ApplicableNCT06388629

Epicardial Access Study With Rook

Epicardial Access Study With Rook (EASY-R)

Sponsor

Circa Scientific, Inc.

Enrollment

40 participants

Start Date

Dec 17, 2023

Study Type

INTERVENTIONAL

Conditions

Arrythmia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
Patient is willing and able to provide written informed consent.

Exclusion Criteria18

Subject is younger than 18 years of age
Previous cardiac surgery
Myocardial infarction within 4 weeks prior to procedure
Class IV NYHA (New York Heart Association) heart failure symptoms
Subject with an active systemic infection
Known carotid artery stenosis greater than 80%
Presence of thrombus in the left atrium
Congenital absence of a pericardium
Coagulopathy
Hemodynamic Instability
Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)
Severe hepatic dysfunction or enlargement
Subject has Body Mass Index > 40
Life expectancy less than 6 months
Subject is pregnant
Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
Subject has known or suspected allergy to contrast media
Subject is known to have pericardial fibrosis, pericardial adhesions, or prior failed epicardial access