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

Henry Ford Health

Status: Completed

Conditions: Left Atrial Appendage Occlusion; Cardiac Catheterization; Atrial Fibrillation; Heart Atria; Cardiac Surgical Procedures; Left Atrial Appendage Ligation; Pneumopericardium; Epicardial Mapping; Pericardium

Treatments: Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06584370

8874

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Pericardial insufflation with CO2

Experimental group

Description:

Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium

Treatment:

Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheter