Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath..
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Steerable Delivery Sheaths on Successful Closure of Left Atrial Appendage With AMULET Dual Mechanism Closure Device (STEER-CLOSE Study)
Overview
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
Interventions
- 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.
Primary outcome measures
- Number of participants with Acute Closure of Left Atrial Appendage [Time frame: 1 day]
- Number of patients with Cardiac Perforation [Time frame: 7 days]
- Need for Pericardiocentesis [Time frame: 7 days]
Secondary outcome measures (5)
- Number of devices [Time frame: 1 day (procedure day)]
- Number of device repositions [Time frame: 1 day (procedure day)]
- Closure Rates [Time frame: 45 days]
- Number of participants with Device related thrombus (DRT) [Time frame: 45 days]
- Number of participants with Transient ischemic attack (TIA) or cerebrovascular accident (CVA) [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 7 centers
- Menorah Medical Center — Overland Park
- Kansas City Heart Rhythm Institute — Overland Park
- Overland Park Regional Medical Center — Overland Park
- Centerpoint Medical Center Clinic — Independence
- Centerpoint Medical Center — Independence
- Research Medical Center Clinic — Kansas City
- Research Medical Center — Kansas City
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. PMID 23008509
- 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. PMID 25399274
- 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. PMID 27898435
- 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 2 PMID 34459659
- 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. PMID 34620400
Identifiers
NCT: NCT05464511 · KCHRRF-STEERRCLOSE-0015