18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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· At 12-months
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)
* Bleedin
Group
Value
95% CI
Amulet
14.5
WATCHMAN (Control)
14.7
Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)Primary· At 18-months
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
Group
Value
95% CI
Amulet
2.8
WATCHMAN (Control)
2.8
Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)Primary· At 45-days
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.
Group
Value
95% CI
Amulet
98.9
WATCHMAN (Control)
96.8
Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)Secondary· At 18-months
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/unexpl
Group
Value
95% CI
Amulet
5.6
WATCHMAN (Control)
7.7
Rate of Major Bleeding (Superiority Analysis)Secondary· At 18-months
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
Group
Value
95% CI
Amulet
11.6
WATCHMAN (Control)
12.3
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)Secondary· At 12-months
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)
* Bleedin
Group
Value
95% CI
Amulet
14.5
WATCHMAN (Control)
14.7
Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic EmbolismSecondary· At 18-months
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
Group
Value
95% CI
Amulet
2.8
WATCHMAN (Control)
2.8
Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core LabSecondary· At 45-days
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.
Group
Value
95% CI
Amulet
98.9
WATCHMAN (Control)
96.8
Composite Rate of Ischemic Stroke and Systemic EmbolismSecondary· 5 Years
Ischemic Stroke is defined as an acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue and Systemic Embolism is define as Acute vascular insufficiency or occlusion of the extremities or any 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 o
Group
Value
95% CI
Amulet
7.4
WATCHMAN (Control)
7.1
Composite Rate of Stroke, Systemic Embolism, or CV/Unexplained DeathSecondary· 5 Years
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/unexpl
Group
Value
95% CI
Amulet
20.3
WATCHMAN (Control)
20.7
Rate of Major BleedingSecondary· 5 Years
Major bleeding:
Type 3a: Any transfusion with overt bleeding. Overt bleeding plus a hemoglobin drop of ≥ 3 to \< 5 g/dL.
Type 3b: Overt bleeding plus hemoglobin drop ≥ 5 g/dL. Cardiac tamponade. Bleeding requiring surgical intervention for Watchman (excluding dental/nasal/skin/ hemorrhoid). Bleeding requiring intravenous vasoactive drugs.
Type 3c:Intracranial hemorrhage including subdural hemorrhages (does not include microbleeds or hemorrhagic transformation, does include intraspinal). Subcategories confirmed by autopsy or imaging or lumbar puncture. Intraocular bleed compromising vision.
Group
Value
95% CI
Amulet
20.1
WATCHMAN (Control)
20.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Amulet
Serious: 542/934 (58%)
Deaths: 251/934
WATCHMAN (Control)
Serious: 535/944 (57%)
Deaths: 263/944
Serious adverse events (218 terms)
Reaction
System
Amulet
WATCHMAN (Control)
Congestive Heart Failure
Cardiac disorders
—
—
Gastrointestinal Bleeding
Gastrointestinal disorders
—
—
Ischemic Stroke
Nervous system disorders
—
—
Cardiac Arrest
Cardiac disorders
—
—
Anemias
Blood and lymphatic system disorders
—
—
Trauma
Injury, poisoning and procedural complications
—
—
Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
—
—
Anterior Myocardial Infarction
Cardiac disorders
—
—
Other
General disorders
—
—
Pneumonia
Infections and infestations
—
—
Encephalopathy
Nervous system disorders
—
—
Sepsis
Infections and infestations
—
—
Chest Pain
Cardiac disorders
—
—
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
—
—
Transient Ischemic Attack (TIA)
Nervous system disorders
—
—
Pericardial Tamponade
Cardiac disorders
—
—
Pericardial Effusion
Cardiac disorders
—
—
Multiple Organ Failure
General disorders
—
—
Hematuria
Renal and urinary disorders
—
—
Syncope
Vascular disorders
—
—
Bleeding
Vascular disorders
—
—
Coronary Artery Disease
Cardiac disorders
—
—
Fall
Injury, poisoning and procedural complications
—
—
Epistaxis
Vascular disorders
—
—
Other adverse events (132 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke
· recruiting
NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment
· NA
· recruiting
NCT07356011 — Exoskeleton for Balance
· NA
· recruiting
NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in
· NA
· recruiting
NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 26 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02879448.