NCT06388629

Epicardial Access Study With Rook

Epicardial Access Study With Rook (EASY-R)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Circa Scientific, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-17
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2024-04-29
• Last updated: 2024-08-21

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study