Actively Recruiting
Epicardial Access Study With Rook
Led by Circa Scientific, Inc. · Updated on 2024-08-21
40
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Epicardial Access Study With Rook
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Czechia, 15030
Actively Recruiting
Research Team
D
David Director of Product Development
CONTACT
A
Alice Regulatory Affairs Manager, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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