Clinical Trials Directory

Trials / Completed

CompletedNCT06584370

Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation

Transatrial Pericardial Separation to Enhance the Safety of Subxiphoid Pericardial Access for Lariat Lariat Left Atrial Appendage Ligation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Henry Ford Health System · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPericardial insufflation with carbon dioxide through a transatrial microcatheterSeparate the walls of the pericardium by insufflating the pericardial space with carbon dioide.

Timeline

Start date
2014-05-01
Primary completion
2015-06-01
Completion
2015-08-01
First posted
2024-09-04
Last updated
2024-09-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06584370. Inclusion in this directory is not an endorsement.