Epicardial Access Study With Rook

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Conditions2

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