| NCT ID | NCT06388629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Circa Scientific, Inc. |
| Condition | Arrythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-17 |
| Primary Completion | 2024-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-12-17 with a primary completion date of 2024-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Petr Neuzil, MD
PRINCIPAL INVESTIGATOR
Nemocnice Na Homolce
Frequently Asked Questions
Who can join the NCT06388629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06388629 currently recruiting?
Yes, NCT06388629 is actively recruiting participants. Contact the research team at david.willenbrink@circascientific.com for enrollment information.
Where is the NCT06388629 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06388629 clinical trial?
NCT06388629 is sponsored by Circa Scientific, Inc.. The principal investigator is Petr Neuzil, MD at Nemocnice Na Homolce. The trial plans to enroll 40 participants.