Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET

Launched by KANSAS CITY HEART RHYTHM RESEARCH FOUNDATION · Jul 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of device called the Amplatzer steerable delivery sheath, which is used during a procedure to close off a part of the heart called the left atrial appendage (LAA). This procedure is important for patients with atrial fibrillation, a condition that can increase the risk of stroke. The researchers want to compare the results of using this new steerable sheath with a traditional non-steerable sheath during the implantation of the Amulet device, which helps prevent strokes.

To participate in this trial, you should be between the ages of 65 and 74 and have atrial fibrillation that requires this type of closure procedure. However, if you are pregnant, breastfeeding, or have had a different device implanted, you won't be eligible. If you decide to take part, you will receive the Amulet device, and your progress will be monitored to see how well the steerable sheath works compared to the traditional one. This study is still in the planning stages, so it hasn't started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device
• Exclusion Criteria:
• • Patient been/being implanted with device other than Amplatzer™ Amulet™ Left Atrial Appendage Occluder
• • Pregnant or breastfeeding patients
• • Prisoners
• • Patients not willing to participate in the study