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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Catheterization Cardiac Surgical Procedures Cardiovascular Diseases Epicardial Mapping Heart Atria Heart Diseases Left Atrial Appendage Ligation Left Atrial Appendage Occlusion Pathologic Processes Pathological Conditions, Signs and Symptoms Pericardium Pneumopericardium

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericardial insufflation with carbon dioxide through a transatrial microcatheter

Procedure

Separate the walls of the pericardium by insufflating the pericardial space with carbon dioide.

Primary outcomes

Successful subxiphoid needle access without myocardial injury

Time frame: Immediate

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 4, 2024
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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