Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

Launched by KANSAS CITY HEART RHYTHM RESEARCH FOUNDATION · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 4D Intracardiac echocardiography (4D-ICE) to see if it can help doctors get a better view of the heart during a procedure called Left Atrial Appendage Closure (LAAC). This procedure is often done for patients with Atrial Fibrillation, a condition that can increase the risk of stroke. The goal is to find out if 4D-ICE can provide clearer images compared to the traditional method known as Transesophageal echocardiography (TEE). The study will involve about 52 participants, who will be followed for a year after the procedure.

To be eligible for this trial, participants should be between 18 and 80 years old and have a history of Atrial Fibrillation or Atrial flutter. They also need to be undergoing the LAAC procedure using specific devices. However, those who cannot give consent, have complex heart anatomy, or other specific health issues may not be able to participate. If someone chooses to take part in the trial, they can expect close monitoring and support throughout the study period, which lasts for 12 months. This trial is currently recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male/Females
• • Age:18-80 years
• • History of Atrial Fibrillation/Atrial flutter
• • Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device
• Exclusion Criteria:
• • Inability or unwillingness of an individual to give written informed consent
• • Patient not following with our practice after the procedure
• • Complex anatomy for endocardial LAAC
• • Thrombus in LAA
• • Patients with pericardial effusion in pre-op TEE/CCTA
• • Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)