Epicardial Access Study With Rook

Launched by CIRCA SCIENTIFIC, INC. · Apr 24, 2024

Keywords

ClinConnect Summary

The Epicardial Access Study is looking into a new device called the Circa Scientific Rook® Epicardial Access Kit, which is used to help doctors reach the outer surface of the heart during certain heart procedures for patients with arrhythmia (irregular heartbeats). The main goals are to see how well this device works and to check whether it is safe compared to other methods currently used to access this part of the heart.

To participate in this study, you need to be an adult who requires a procedure that involves accessing the pericardial space, which is the area around the heart. This study is open to all genders and is currently recruiting participants aged 65 to 74. If you join, you will receive treatment with the Rook device during a regular heart procedure. However, there are some health conditions that might prevent you from participating, such as serious heart problems, recent heart surgery, or certain infections. If you’re interested, your doctor can help determine if you meet the eligibility criteria.

Gender

ALL

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 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