AMPLATZER* Amulet* Left Atrial Appendage (LAA) Occluder <br>Randomized Controlled Trial <br>

Recruiting

Conditions: abnormal heart rhythm
Atrial Fibrillation (AF)
10007521

Registration Number: NL-OMON47281

Lead Sponsor: St. Jude Medical

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. 18 years of age or older
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation and the
patient has not been diagnosed with rheumatic mitral valvular heart disease
3. At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc
score of > 3
4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulant medication
5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take
long term anticoagulation, following the conclusion of shared decision making (see inclusion
criteria #6)
6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including
an independent non-interventional physician) involved in the formal and shared decision-making
process, and by use of an evidence-based decision tool on oral anticoagulation (final
determination must be documented in the subject*s medical record)
7. Able to comply with the required medication regime post-device implant
8. Able to understand and is willing to provide written informed consent to participate in the trial
9. Able and willing to return for required follow-up visits and examinations

Exclusion Criteria

1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
3. Indicated for chronic P2Y12 platelet therapy inhibitor
4. Is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay (criterion is only applicable where general anesthesia is planned for the study procedure)
5. Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
6. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
7. Implanted with a mechanical valve prosthesis
8. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g.
subject is too small to accommodate the TEE/TOE probe or required catheters, or subject has
active infection or bleeding disorder)
9. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant
procedure (as applicable)
10. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to
randomization, or intervention or surgery is planned within 60 days after implant procedure (e.g.
cardioversion, ablation, cataract surgery, etc.)
11. Myocardial infarction (MI) within 90 days prior to randomization
12. New York Heart Association Class IV Congestive Heart Failure
13. Left ventricular ejection Fraction (LVEF) <30%
14. Symptomatic carotid disease (defined as >50% stenosis with symptoms of ipsilateral transient
or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if
subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50%
stenosis
15. Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma,
recent major surgical procedures)
16. History of idiopathic or recurrent venous thromboembolism
17. Left atrial appendage is obliterated or surgically ligated
18. Thrombocytopenia or anemia requiring transfusions
19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
21. Subject is pregnant or pregnancy is planned during the course of the investigation
22. Active endocarditis or other infection producing bacteremia
23. Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
24. Subjects with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2)
25. Subject whose life expectancy is less than 2 years
26. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator*s opinion, could limit the subject*s ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.;To participate in the trial, subjects must not meet any of the following echocardiographic exclusion criteria:
1. Intracardi

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The trial has three primary endpoints to compare safety and effectiveness of<br /><br>the Amulet device against the Control device:<br /><br>Safety<br /><br>A composite of procedure-related complications, or all-cause death, or major<br /><br>bleeding through 12 months<br /><br><br /><br>Effectiveness<br /><br>A composite of ischemic stroke or systemic embolism through 18 months<br /><br><br /><br>Mechanism of Action<br /><br>Device closure (defined as residual jet around the device <= 5 mm) at the 45-day<br /><br>visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler<br /><br>flow</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The trial will also compare the Amulet device to the Control device for the<br /><br>following secondary endpoints:<br /><br>• A composite of all stroke, systemic embolism, or cardiovascular/unexplained<br /><br>death at 18 months post-implant<br /><br>• Major bleeding rate at 18 months post-implant: defined as Type 3 or greater<br /><br>based on the Bleeding Academic Research Consortium (BARC)<br /><br>definition<br /><br>• A composite of procedure-related complications, or all-cause death, or major<br /><br>bleeding through 12 months (superiority analysis)<br /><br>• A composite of ischemic stroke or systemic embolism through 18 months<br /><br>(superiority analysis)<br /><br>• Device closure (defined as residual jet around the device <= 5 mm) at the<br /><br>45-day visit documented by transesophageal echocardiogram<br /><br>(TEE/TOE) defined by Doppler flow (superiority analysis)</p><br>