Epicardial Access Study With Rook

Arrythmia Clinical Trial

— EASY-R  

Official title:

Epicardial Access Study With Rook (EASY-R)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388629
• Other study ID #: M064-066 Rev 00
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Circa Scientific, Inc.
• Contact: David Director of Product Development
• Phone: (303) 951-8767
• Email: david.willenbrink[@]circascientific.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia

Intervention

Device:
• Rook Epicardial Access Kit
Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Circa Scientific, Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Adverse Events	The rate of occurrence of adverse events that have been determined to be related to the device by the clinical events committee	Patients are monitored for adverse events until hospital discharge or up to 4 day after procedure.
Primary	Successful Epicardial Access	The number and percentage of patients in which successful epicardial access is achieved	During procedure.
Secondary	Speed of Access	The time from skin incision to confirmed guidewire access to the pericardial space	During procedure.
Secondary	Rate of Use Errors	Recording any use errors that may occur in the clinical environment that have not been otherwise been observed.	During procedure.