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

NCT ID: NCT05464511

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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

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

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with Amulet device using non-steerable fixed curve sheath

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patients with Amulet device using a novel steerable sheath

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansas City Heart Rhythm Institute

OTHER

Sponsor Role: collaborator

Kansas City Heart Rhythm Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dhanunjaya Lakkireddy

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Institute

Locations

Menorah Medical Center

Overland Park, Kansas, United States

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Centerpoint Medical Center Clinic

Independence, Missouri, United States

Centerpoint Medical Center

Independence, Missouri, United States

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

Countries

United States

Central Contacts

Donita Atkins

Role: CONTACT

datkins@kchrf.com

816-651-1969

References

Gangireddy SR, Halperin JL, Fuster V, Reddy VY. Percutaneous left atrial appendage closure for stroke prevention in patients with atrial fibrillation: an assessment of net clinical benefit. Eur Heart J. 2012 Nov;33(21):2700-8. doi: 10.1093/eurheartj/ehs292. Epub 2012 Sep 24.

Reference Type: BACKGROUND

PMID: 23008509 (View on PubMed)

Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

Reference Type: BACKGROUND

PMID: 25399274 (View on PubMed)

Jazayeri MA, Vuddanda V, Parikh V, Lakkireddy DR. Percutaneous left atrial appendage closure: current state of the art. Curr Opin Cardiol. 2017 Jan;32(1):27-38. doi: 10.1097/HCO.0000000000000367.

Reference Type: BACKGROUND

PMID: 27898435 (View on PubMed)

Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O'Brien L, Windecker S. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021 Nov 9;144(19):1543-1552. doi: 10.1161/CIRCULATIONAHA.121.057063. Epub 2021 Aug 30.

Reference Type: BACKGROUND

PMID: 34459659 (View on PubMed)

Saw J, Perrin N, Nestelberger T, Mondesert B, Tsang M, Ibrahim R. First-in-Human Experience With the Amplatzer Steerable Delivery Sheath for Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2021 Oct 11;14(19):2191-2193. doi: 10.1016/j.jcin.2021.07.022. No abstract available.

Reference Type: BACKGROUND

PMID: 34620400 (View on PubMed)

Other Identifiers

KCHRRF-STEERRCLOSE-0015

Identifier Type: -

Identifier Source: org_study_id