Randomized, controlled study to assess the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder (Implant for closure of the left atrial appendage)

Australia, Canada, Czechia, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United States (ICTRP)

ICTRP Trial ID
NCT02879448 (ICTRP)

Official title (approved by ethics committee)
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial (BASEC)

Academic title
AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (ICTRP)

Public title
AMPLATZER Amulet LAA Occluder Trial (ICTRP)

Disease under investigation
Stroke (ICTRP)

Intervention under investigation
Device: Amulet Left Atrial Appendage OccluderDevice: WATCHMAN Left Atrial Appendage Closure (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion criteria
Inclusion Criteria:

1. 18 years of age or older

2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation
(AF) 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
anticoagulation medication

5. Deemed by investigator to be suitable for short term warfarin therapy but deemed
unable to take long term oral 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 regimen post-device implant

8. Able to understand and 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 transesophageal
echocardiogram (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 artery 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 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
<30ml/min/1.73m)

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.

Echocardiographic Exclusion Criteria:

1. Intracardiac thrombus visualized by echocardiographic imaging

2. Existing circumferential pericardial effusion >2mm

3. Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm^2)

4. High risk PFO, defined as an atrial septal aneurysm (excursion > 15mm or length =
15mm excursion defined as maximal protrusion of the atrial septal aneurysm [ASA]
beyond the plane of the atrial septum) or large shunt (early, within 3 beats and/or
substantial passage of bubbles i.e. = 20)

5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch

6. Cardiac tumor

7. LAA anatomy cannot accommodate either a Boston Scientific LAA closure device or
Amulet device, as per manufacturer's Instructions for Use (IFU). (i.e. the LAA
anatomy and sizing must be appropriate for both devices in order to be enrolled in
the trial. This is applicable to all roll-in and randomized subjects).

8. Placement of the device would interfere with any intracardiac or intravascular
structure (ICTRP)

not available

Primary and secondary end points
Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition) (Non-inferiority Analysis);Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis);Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) (ICTRP)

Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis);Rate of Major Bleeding (Superiority Analysis);Superiority Test of Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition);Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism;Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Dhanunjaya Lakkireddy, MD;David Thaler, MD, PhD;Stephan Windecker, MD, PhD, University of Kansas,The Comprehensive Stroke Center at Tufts Medical Center,Inselspital, University of Bern (ICTRP)

Secondary trial IDs
SJM-CIP-10114 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT02879448 (ICTRP)