Clinical trial NCT06388629: Epicardial Access Study With Rook
Official title: Epicardial Access Study With Rook (EASY-R)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrythmia
Keywords: Electrophysiology
Pericardial Access
Epicardial Access
EP
Lead sponsor: Circa Scientific, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized
Primary purpose: OTHER

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.

Detailed description: This trial is a confirmatory trial for the Circa Scientific Rook® Epicardial Access Kit for accessing the epicardial surface of the heart via a subxiphoid approach to facilitate guidewire placement into the pericardial space in adult patients. The purpose of this study is to confirm the safety and establish the efficacy of the Circa Scientific Rook® Epicardial Access Kit as a pericardial access device. The Rook® Epicardial Access Kit will be used to gain access the epicardial surface of the heart via a subxiphoid approach in adult patients with a normal, non-distended pericardial space.

Access success of the test device to the pericardial space and occurrence of CEC-adjudicated device and procedure related adverse events will be assessed in relation to complication rate existing data from the literature presenting epicardial access procedure results during subxiphoid (minimally invasive) surgical procedures. This is a prospective, single-arm, non-randomized study.

The primary endpoint is successful pericardial access through the use of the Circa Scientific Rook® Epicardial Access Kit, achieving guidewire access to the pericardial space as confirmed during the procedure by standard x-ray technique. The safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through hospital discharge or up to 4 days post procedure, whichever comes first. Additional endpoints include speed of access, ease of use and human factors data.

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

Primary outcomes:
measure: Successful Epicardial Access
timeFrame: During procedure.
Secondary outcomes:
measure: Speed of Access
timeFrame: During procedure.
measure: Rate of Use Errors
timeFrame: During procedure.
Other outcomes:
measure: Rate of Adverse Events
timeFrame: Patients are monitored for adverse events until hospital discharge or up to 4 day after procedure.
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
Study officials:
affiliation: Nemocnice Na Homolce
name: Petr Neuzil, MD
role: PRINCIPAL_INVESTIGATOR
References: