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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pericardial insufflation with CO2 | Experimental | Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pericardial insufflation with carbon dioxide through a transatrial microcatheter | Procedure | Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful subxiphoid needle access without myocardial injury | Immediate |
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Inclusion Criteria:
Exclusion Criteria:
• Does not consent to participate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20971258 | Background | Cohn WE, Winkler JA, Tuzun E, Hjelle A, Bassett K, Ahmad A, Frazier OH. Contrast pericardiography facilitates intrapericardial navigation under fluoroscopy. Ann Thorac Surg. 2010 Nov;90(5):1537-40. doi: 10.1016/j.athoracsur.2010.06.025. | |
| 25315516 | Result | Rogers T, Ratnayaka K, Schenke WH, Faranesh AZ, Mazal JR, O'Neill WW, Greenbaum AB, Lederman RJ. Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access. Catheter Cardiovasc Interv. 2015 Aug;86(2):E111-8. doi: 10.1002/ccd.25698. Epub 2014 Oct 28. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D011026 | Pneumopericardium |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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