Left Atrial Appendage Occlusion with AMULET using Steerable Delivery Sheaths for Stroke and Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+6 other locations

Dhanunjaya DJ Lakkireddy MD, Clinical ...

Overseen byDhanunjaya Lakkireddy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Kansas City Heart Rhythm Research Foundation

No Placebo Group

Trial Summary

What is the purpose of this trial?The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.

Eligibility Criteria

This trial is for patients with atrial fibrillation who need a left atrial appendage occlusion, specifically using the Amplatzer™ Amulet™ device. It's not for prisoners, pregnant or breastfeeding individuals, those unwilling to participate, or patients using different devices.

Inclusion Criteria

You have atrial fibrillation and are having a specific heart device implanted.

Exclusion Criteria

Prisoners

Pregnant or breastfeeding patients

Patients not willing to participate in the study

+1 more

Participant Groups

The study compares two methods of closing off the left atrial appendage in heart patients: one uses a traditional non-steerable sheath and the other uses a new steerable sheath with the aim to see if one results in better outcomes.

2Treatment groups

Active Control

Group I: Patients with Amulet device using non-steerable fixed curve sheathActive Control1 Intervention

Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath.

Group II: Patients with Amulet device using a novel steerable sheathActive Control1 Intervention

Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.