Epicardial Access Study With Rook
- Conditions
- Arrythmia
- Registration Number
- NCT06388629
- Lead Sponsor
- Circa Scientific, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> 1. Patient is clinically indicated to undergo a procedure that requires percutaneous<br> access to the normal, non-distended, pericardial space.<br><br> 2. Patient is willing and able to provide written informed consent.<br><br>Exclusion Criteria:<br><br> 1. Subject is younger than 18 years of age<br><br> 2. Previous cardiac surgery<br><br> 3. Myocardial infarction within 4 weeks prior to procedure<br><br> 4. Class IV NYHA (New York Heart Association) heart failure symptoms<br><br> 5. Subject with an active systemic infection<br><br> 6. Known carotid artery stenosis greater than 80%<br><br> 7. Presence of thrombus in the left atrium<br><br> 8. Congenital absence of a pericardium<br><br> 9. Coagulopathy<br><br> 10. Hemodynamic Instability<br><br> 11. Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)<br><br> 12. Severe hepatic dysfunction or enlargement<br><br> 13. Subject has Body Mass Index > 40<br><br> 14. Life expectancy less than 6 months<br><br> 15. Subject is pregnant<br><br> 16. Subject is currently participating in another investigational drug or device study<br> that clinically interferes with the endpoints of this study<br><br> 17. Subject has known or suspected allergy to contrast media<br><br> 18. Subject is known to have pericardial fibrosis, pericardial adhesions, or prior<br> failed epicardial access
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful Epicardial Access
- Secondary Outcome Measures
Name Time Method Speed of Access;Rate of Use Errors