Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388629
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-20
Brief Title:
Epicardial Access Study With Rook
Sponsor:
Circa Scientific Inc
Organization:
Circa Scientific Inc
Study Overview
Official Title:
Epicardial Access Study With Rook EASY-R
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASY-R
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None