Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584370
Status:
COMPLETED
Last Update Posted:
None
First Post:
2015-04-29
Brief Title:
Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We use a tiny catheter through the heart to separate the pericardium with gas We expect this to improve the safety of the Lariat procedure
Detailed Description:
The Lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation Subxiphoid needle access to the pericardium a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone during Lariat risks injury to the heart surface that requires surgical repair
In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium Before needle access the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole The investigators then inject gas to push the heart away from the pericardial needle This reduces the risk of injuring the heart during the standard Lariat procedure
In this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium Before needle access the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole The investigators then inject gas to push the heart away from the pericardial needle This reduces the risk of injuring the heart during the standard Lariat procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None