Atrial Fibrillation, Cardiac Catheterization, Cardiac Surgical Procedures, Epicardial Mapping, Heart Atria, Left Atrial Appendage Ligation, Left Atrial Appendage Occlusion, Pericardium, Pneumopericardium
Conditions
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.
Interventions
PROCEDUREPericardial insufflation with carbon dioxide through a transatrial microcatheter
Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.
Sponsors
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing subxiphoid access to the empty pericardial space as part of a Lariat left atrial appendage exclusion procedure * Age ≥ 21 years
Exclusion criteria
• Does not consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful subxiphoid needle access without myocardial injury | Immediate |
Countries
United States
Outcome results
None listed