Testing a new device for accessing the heart's surface
Epicardial Access Study With Rook (EASY-R)
NA · Circa Scientific, Inc. · NCT06388629
This study is testing a new device to see if it can safely and effectively help doctors reach the surface of the heart during a minimally invasive procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Circa Scientific, Inc. (industry) |
| Locations | 1 site (Prague) |
| Trial ID | NCT06388629 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of the Circa Scientific Rook® Epicardial Access Kit for gaining access to the epicardial surface of the heart using a minimally invasive subxiphoid approach. Participants will undergo a typical electrophysiology procedure where the device will be used to facilitate guidewire placement into the pericardial space. The study aims to confirm the device's safety and efficacy by comparing access success rates and adverse events with existing literature on similar procedures. The primary endpoint focuses on successful access to the pericardial space, while secondary endpoints include the speed of access and ease of use.
Who should consider this trial
Good fit: Ideal candidates are adults who require percutaneous access to the normal, non-distended pericardial space for an electrophysiology procedure.
Not a fit: Patients with recent cardiac surgery, severe heart failure, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of procedures requiring access to the heart's surface, potentially leading to better patient outcomes.
How similar studies have performed: While this approach is being tested in this trial, similar studies have shown varying success with alternative epicardial access methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- Na Homolce Hospital — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Petr Neuzil, MD — Nemocnice Na Homolce
- Study coordinator: David Director of Product Development
- Email: david.willenbrink@circascientific.com
- Phone: (303) 951-8767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arrythmia, Electrophysiology, Pericardial Access, Epicardial Access, EP