Transatrial Pericardial Separation to Enhance Safety of Subxiphoid Pericardial Access for Left Atrial Appendage Ligation
NCT ID: NCT06584370
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2014-05-31
2015-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pericardial insufflation with CO2
Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium
Pericardial insufflation with carbon dioxide through a transatrial microcatheter
Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.
Interventions
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Pericardial insufflation with carbon dioxide through a transatrial microcatheter
Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 21 years
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Adam Greenbaum
Co-Director, Structural Heart Disease Program
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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References
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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.
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.
Other Identifiers
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8874
Identifier Type: -
Identifier Source: org_study_id
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