Epicardial Access Study With Rook

NCT ID: NCT06388629

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-17
• Study Completion Date: 2024-10-15

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.

Conditions

Arrythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm

Single arm of the study that receives treatment with the subject device.

Group Type: EXPERIMENTAL

Rook Epicardial Access Kit

Intervention Type: DEVICE

Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Circa Scientific, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Neuzil, MD

Role: PRINCIPAL_INVESTIGATOR

Nemocnice Na Homolce

Locations

Na Homolce Hospital

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

David Director of Product Development

Role: CONTACT

david.willenbrink@circascientific.com

(303) 951-8767 ext. 201

Alice Regulatory Affairs Manager, PhD

Role: CONTACT

Alice.Ouyang@circascientific.com

(303) 951-8767

Facility Contacts

Petr Neuzil, MD, PhD

Role: primary

+420257272211

Other Identifiers

M064-066 Rev 00

Identifier Type: -

Identifier Source: org_study_id