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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02879448
Ethics application status
Date submitted
22/08/2016
Date registered
25/08/2016

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
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)
Assessment method [1] 0 0
Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of = 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop = 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding * Type 5b: Definite fatal bleeding
Timepoint [1] 0 0
At 12-months
Primary outcome [2] 0 0
Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)
Assessment method [2] 0 0
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.
Timepoint [2] 0 0
At 18-months
Primary outcome [3] 0 0
Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)
Assessment method [3] 0 0
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 was assessed.
Timepoint [3] 0 0
At 45-days
Secondary outcome [1] 0 0
Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)
Assessment method [1] 0 0
Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion. Cardiovascular/unexplained death includes: * Death due to proximate cardiac cause * Death caused by non-coronary/non-CNS vascular conditions * Death from vascular CNS causes * All procedure-related deaths * Sudden/unwitnessed death * Death of unknown cause
Timepoint [1] 0 0
At 18-months
Secondary outcome [2] 0 0
Rate of Major Bleeding (Superiority Analysis)
Assessment method [2] 0 0
Major bleeding rate defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition was assessed * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of = 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop = 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging * Type 5b: Definite fatal bleeding: bleeding that is directly observed or confirmed on autopsy
Timepoint [2] 0 0
At 18-months
Secondary outcome [3] 0 0
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)
Assessment method [3] 0 0
Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of = 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop = 5 g/dL (provided Hb drop is related to bleed) * Cardiac tamponade * Bleeding requiring surgical intervention for (Watchman) * Bleeding requiring intravenous vasoactive drugs * Type 3c: * Intracranial hemorrhage including subdural hemorrhages * Subcategories confirmed by autopsy/imaging/lumbar puncture * Intraocular bleed compromising vision * Type 5a: Probably fatal bleeding * Type 5b: Definite fatal bleeding
Timepoint [3] 0 0
At 12-months
Secondary outcome [4] 0 0
Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
Assessment method [4] 0 0
Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.
Timepoint [4] 0 0
At 18-months
Secondary outcome [5] 0 0
Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab
Assessment method [5] 0 0
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 was assessed.
Timepoint [5] 0 0
At 45-days

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 and willing to return for required follow-up visits and examinations
Minimum age
18 Years
Maximum age
No limit
Sex
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. 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/1.73m²)
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.

Echocardiographic

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

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/05/2024
Sample size
Target
Accrual to date
Final
1878
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
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United States of America
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Alabama
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Hesse
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Hamburg
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Bern

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Email 0 0
Contact person for public queries
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Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02879448