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

Study Overview
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Brief Summary
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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.

Detailed Description
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Atrial fibrillation (AF) is the most common abnormal heart rhythm associated with substantial morbidity and mortality. It is one of the strongest risk factors of systemic thromboembolism (TE), with stroke being the most serious outcome. Prevention of stroke is the cornerstone of managing AF, which can be achieved either by oral anticoagulation (OAC) or Percutaneous left atrial appendage occlusion (LAAO) in patients who have a contraindication to OAC. Heterogeneity in cardiac chamber size, interatrial septum, LAA anatomy and orientation, operator experience and currently available fixed curve sheaths add to the complexity of the procedure. Alignment of LAAO device along the access of the left atrial appendage body is an important factor in improving closure rates. The devices which are currently approved by FDA for LAA closure in the U.S. are Amplatzer Amulet device (Abbott Medical) and Watchman and Watchman FLX devices (Boston Scientific). In a recent study, Amplatzer Amulet device was found to be noninferior in terms of safety and effectiveness, with superior LAA occlusion rates but higher device-related complications as compared to first generation watchman device. The LAAO device sheaths that are used currently have fixed shapes and angles that may not be optimal for some LAA anatomy, which can lead to excessive device manipulation, prolonged procedure time, and potentially suboptimal co-axiality during the process. This may lead to increase device related complications. The new Amplatzer steerable delivery sheath (Abbott Vascular) is designed to provide distal bidirectional steerability of the sheath for Amulet implantation. Such steerability may enable successful endovascular closure of greater proportion of LAA, allow precise position of the transseptal puncture, and potentially reduce procedural times and complications with complex cases. Investigators hypothesize that the use of novel steerable sheath for LAAO closure is safer and more effective as compared to non-steerable fixed curve sheath

Official Title
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Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Other: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a multi-centered, retrospective as well as prospective observational registry with patients undergoing LAAO with the dual mechanism closure Amulet device. This study will proceed with a target of 300 patients who have undergone or are planned to undergo LAAO with dual mechanism closure Amulet device. Patient level data of participating centers will be obtained from National Cardiovascular Data Registry (NCDR®) of patients who have already had the procedure. Prospective data will be collected for all patients willing to participate in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients with Amulet device using non-steerable fixed curve sheath<br>Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath. | |
| Active Comparator: Patients with Amulet device using a novel steerable sheath<br>Patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath. | Other: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.<br>* Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Acute Closure of Left Atrial Appendage | Acute closure ( less than or equal to 3mm) of the left atrial appendage after Left Atrial Appedage Occlusion(LAAO) procedure | 1 day | 
| Number of patients with Cardiac Perforation | Number of patients with cardiac perforation | 7 days | 
| Need for Pericardiocentesis | Need for pericardiocentesis within 7 days of implantation | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of devices | Number of devices changed prior to final implant during the procedure | 1 day (procedure day) | 
| Number of device repositions | Number of device repositions performed during the procedure | 1 day (procedure day) | 
| Closure Rates | 45 day closure rates of left atrial appendage ( less than or equal to 3mm) | 45 days | 
| Number of participants with Device related thrombus (DRT) | Number of participants with Device related thrombus (DRT) | 45 days | 
| Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA) | Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of the procedure | 6 months |