Epicardial Access Study With Rook (EASY-R)

Epicardial Access Study With Rook (EASY-R)

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.

Study Overview

• Status: Recruiting
• Conditions: Arrythmia
• Intervention / Treatment: Device: Rook Epicardial Access Kit

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Director of Product Development; Phone Number: 201 (303) 951-8767; Email: david.willenbrink@circascientific.com
• Study Contact Backup: Name: Alice Regulatory Affairs Manager, PhD; Phone Number: (303) 951-8767; Email: Alice.Ouyang@circascientific.com

Study Locations

• Czechia
  • Prague, Czechia, 15030
    • Recruiting
    • Na Homolce Hospital
    • Contact: Petr Neuzil, MD, PhD; Phone Number: +420257272211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Single arm of the study that receives treatment with the subject device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Epicardial Access	The number and percentage of patients in which successful epicardial access is achieved	During procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed of Access	The time from skin incision to confirmed guidewire access to the pericardial space	During procedure.
Rate of Use Errors	Recording any use errors that may occur in the clinical environment that have not been otherwise been observed.	During procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Circa Scientific, Inc.
• Investigators: Principal Investigator: Petr Neuzil, MD, Nemocnice Na Homolce

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Electrophysiology; EP; Epicardial Access; Pericardial Access
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: M064-066 Rev 00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes