Trial Parameters
Brief 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 Criteria
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 clinicall