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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05464511
• Other study ID #: KCHRRF-STEERRCLOSE-0015
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Centerpoint Medical Center	Independence	Missouri
United States	Centerpoint Medical Center Clinic	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2015 Mar 10;313(10):1061. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of patients with Cardiac Perforation	Number of patients with cardiac perforation	7 days
Primary	Need for Pericardiocentesis	Need for pericardiocentesis within 7 days of implantation	7 days
Secondary	Number of devices	Number of devices changed prior to final implant during the procedure	1 day (procedure day)
Secondary	Number of device repositions	Number of device repositions performed during the procedure	1 day (procedure day)
Secondary	Closure Rates	45 day closure rates of left atrial appendage ( less than or equal to 3mm)	45 days
Secondary	Number of participants with Device related thrombus (DRT)	Number of participants with Device related thrombus (DRT)	45 days
Secondary	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