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

• Sponsor: Kansas City Heart Rhythm Research Foundation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05464511
• Collaborator: Kansas City Heart Rhythm Institute (Other)
• Enrollment: 300
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site: 42.9
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Stroke	Other: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Other
• Official Title: Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Number of participants with Acute Closure of Left Atrial Appendage [1 day]

   Acute closure ( less than or equal to 3mm) of the left atrial appendage after Left Atrial Appedage Occlusion(LAAO) procedure

2. Number of patients with Cardiac Perforation [7 days]

   Number of patients with cardiac perforation

3. Need for Pericardiocentesis [7 days]

   Need for pericardiocentesis within 7 days of implantation

Secondary Outcome Measures

1. Number of devices [1 day (procedure day)]

   Number of devices changed prior to final implant during the procedure

2. Number of device repositions [1 day (procedure day)]

   Number of device repositions performed during the procedure

3. Closure Rates [45 days]

   45 day closure rates of left atrial appendage ( less than or equal to 3mm)

4. Number of participants with Device related thrombus (DRT) [45 days]

   Number of participants with Device related thrombus (DRT)

5. Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA) [6 months]

   Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months of the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menorah Medical Center	Overland Park	Kansas	United States	66209
2	Kansas City Heart Rhythm Institute	Overland Park	Kansas	United States	66211
3	Overland Park Regional Medical Center	Overland Park	Kansas	United States	66215
4	Centerpoint Medical Center Clinic	Independence	Missouri	United States	64057
5	Centerpoint Medical Center	Independence	Missouri	United States	64057
6	Research Medical Center Clinic	Kansas City	Missouri	United States	64032
7	Research Medical Center	Kansas City	Missouri	United States	64032

Sponsors and Collaborators

• Kansas City Heart Rhythm Research Foundation
• Kansas City Heart Rhythm Institute

Investigators

• Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.
• 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.
• Saw J, Perrin N, Nestelberger T, Mondésert 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.

• Responsible Party: Kansas City Heart Rhythm Research Foundation
• ClinicalTrials.gov Identifier: NCT05464511
• Other Study ID Numbers: KCHRRF-STEERRCLOSE-0015
• First Posted: Jul 19, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jul 19, 2022