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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02879448




Registration number
NCT02879448
Ethics application status
Date submitted
22/08/2016
Date registered
25/08/2016
Date last updated
21/04/2021

Titles & IDs
Public title
AMPLATZER™ Amulet™ LAA Occluder Trial
Scientific title
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial
Secondary ID [1] 0 0
SJM-CIP-10114
Universal Trial Number (UTN)
Trial acronym
Amulet IDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Amulet Left Atrial Appendage Occluder
Treatment: Devices - WATCHMAN Left Atrial Appendage Closure

Experimental: Amulet - Amulet left atrial appendage occluder

Active Comparator: WATCHMAN (Control) - WATCHMAN left atrial appendage closure device


Treatment: Devices: Amulet Left Atrial Appendage Occluder
Transcatheter left atrial appendage closure

Treatment: Devices: WATCHMAN Left Atrial Appendage Closure
Transcatheter left atrial appendage closure

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedure-related complications, all-cause death, major bleeding - The primary safety endpoint is a composite of procedure-related complications, or all-cause death, or major bleeding through 12 months
Timepoint [1] 0 0
12-month
Primary outcome [2] 0 0
Ischemic stroke, systemic embolism - The primary efficacy endpoint is a composite of ischemic stroke or systemic embolism through 18 months
Timepoint [2] 0 0
18-month
Primary outcome [3] 0 0
Device closure - The primary mechanism of action endpoint is device closure (defined as residual jet around the device = 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow
Timepoint [3] 0 0
45-days
Secondary outcome [1] 0 0
All stroke, systemic embolism, or cardiovascular/unexplained death - A composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months post-implant
Timepoint [1] 0 0
18-month
Secondary outcome [2] 0 0
Major bleeding post-device implant - Major bleeding rate at 18 months post-implant: defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition
Timepoint [2] 0 0
18-month

Eligibility
Key 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 to and willing to return for required follow-up visits and examinations
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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. Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted

5. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted

6. Implanted with a mechanical valve prosthesis

7. 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)

8. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or
implant procedure (as applicable)

9. 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 (cardioversion, ablation, cataract surgery, etc.)

10. Myocardial infarction (MI) within 90 days prior to randomization

11. New York Heart Association Class IV Congestive Heart Failure

12. Left ventricular ejection Fraction (LVEF) =30%

13. 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

14. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication,
trauma, recent major surgical procedures)

15. History of idiopathic or recurrent venous thromboembolism

16. Left atrial appendage is obliterated or surgically ligated

17. Thrombocytopenia or anemia requiring transfusions

18. 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)

19. Actively enrolled or plans to enroll in a concurrent clinical study in which the
active treatment arm may confound the results of this trial

20. Subject is pregnant or pregnancy is planned during the course of the investigation

21. Active endocarditis or other infection producing bacteremia

22. Subject has had a transient case of AF (i.e. never previously detected,
provoked/induced by surgical or catheter manipulations, etc.)

23. Subjects with severe renal failure (estimated glomerular filtration rate
<30ml/min/1.73m²

24. Subject whose life expectancy is less than 2 years

25. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Specialist Cardiology - Wahroonga
Recruitment hospital [2] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 0 0
St. Andrew's Hospital - Adelaide
Recruitment hospital [4] 0 0
HeartCare St John of God Wexford Medical Centre - Murdoch
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Tennessee
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Texas
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Utah
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Vermont
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Washington
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West Virginia
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Arhus
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Copenhagen
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Bavaria
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Hesse
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Castile And Leon
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Navarre
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Switzerland
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Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance
is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device
in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial
will be randomized to receive either the Amulet device or the WATCHMAN device and will be
followed for 5 years after device implant.
Trial website
https://clinicaltrials.gov/show/NCT02879448
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dhanunjaya Lakkireddy, MD
Address 0 0
University of Kansas
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications