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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Left Atrial Appendage Ligation; Pericardium; Epicardial Mapping; Heart Atria; Cardiac Surgical Procedures; Cardiac Catheterization; Pneumopericardium; Left Atrial Appendage Occlusion
• Interventions: Procedure: Pericardial insufflation with carbon dioxide through a transatrial microcatheter

• Registration Number: NCT06584370
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-04-29
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pericardial insufflation with CO2	Pericardial insufflation with carbon dioxide through a transatrial microcatheter	Intentional transatrial introduction of a microcatheter to insufflate the pericardium with carbon dioxide, to separate the walls of the pericardium

Primary Outcome Measures

Name	Time	Method
Successful subxiphoid needle access without myocardial injury	Immediate

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States