Actively Recruiting
Epicardial Access Study With Rook (EASY-R)
Led by Circa Scientific, Inc. · Updated on 2024-08-21
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Circa Scientific Rook4 Epicardial Access Kit to see how well it can gain guidewire access to the outside surface of the heart, known as the epicardium. The study focuses on adult patients undergoing typical epicardial electrophysiology procedures and aims to confirm the device's safety and effectiveness compared to existing methods for epicardial access. This is a prospective, single-arm, non-randomized trial designed to assess performance and safety outcomes. Participants will receive treatment using the Rook4 Epicardial Access Kit, which accesses the epicardial surface through a subxiphoid approach to place a guidewire into the pericardial space. This device is used during the procedure, and there is only one study group receiving this treatment. The study will measure success in gaining epicardial access, speed of access, ease of use, and any device or procedure-related adverse events. During the study, researchers will confirm successful access to the pericardial space using standard x-ray techniques. Safety will be monitored up to hospital discharge or for up to four days after the procedure. Data on procedure speed, ease of use, and any errors will also be collected. Participants will be closely observed during the hospital stay to evaluate these outcomes and ensure safety throughout the process.
CONDITIONS
Brief Title
Epicardial Access Study With Rook
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
- Patient is willing and able to provide written informed consent.
- Age 18 years or older.
You will not qualify if you...
- Subject is younger than 18 years of age.
- Previous cardiac surgery.
- Myocardial infarction within 4 weeks prior to procedure.
- Class IV NYHA heart failure symptoms.
- Active systemic infection.
- Known carotid artery stenosis greater than 80%.
- Presence of thrombus in the left atrium.
- Congenital absence of a pericardium.
- Coagulopathy.
- Hemodynamic instability.
- Acute conditions such as electrolyte abnormality, acute ischemia, or drug toxicity.
- Severe hepatic dysfunction or enlargement.
- Body Mass Index greater than 40.
- Life expectancy less than 6 months.
- Pregnancy.
- Currently participating in another investigational drug or device study that interferes with this study.
- Known or suspected allergy to contrast media.
- Known pericardial fibrosis, adhesions, or prior failed epicardial access.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus up to 4 days post-procedure
Participants undergo the procedure using the Rook Epicardial Access Kit to gain access to the epicardial surface of the heart via a subxiphoid approach.
1 procedure visit and up to 4 days of hospital observation
Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Czechia, 15030
Actively Recruiting
Research Team
D
David Director of Product Development
A
Alice Regulatory Affairs Manager, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here