Trial · NCT02879448
AMPLATZER™ Amulet™ LAA Occluder Trial
NCT02879448, Not applicable, Completed, Abbott Medical Devices; results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AMPLATZER™ Amulet™ LAA Occluder Trial. Trials, record NCT02879448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02879448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMPLATZER™ Amulet™ LAA Occluder Trial
- NCT number
- NCT02879448
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,878 participants, actual
- Lead sponsor
- Abbott Medical Devices
- Conditions
- Stroke
- Interventions
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- First posted
- 2016-08-25
- Last updated
- 2025-02-26
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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) * 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 |
| Primary | Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis) | 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 occlusion. |
| Primary | Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) | 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. |
| Secondary | Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis) | 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/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 |
| Secondary | Rate of Major Bleeding (Superiority Analysis) | 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/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 |
| Secondary | 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) | 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) * 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 |
| Secondary | Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism | 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 occlusion. |
| Secondary | Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab | 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. |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | At 12-months | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| PRIMARY | Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis) | At 18-months | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| PRIMARY | Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) | At 45-days | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| SECONDARY | Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis) | At 18-months | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| SECONDARY | Rate of Major Bleeding (Superiority Analysis) | At 18-months | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| SECONDARY | 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) | At 12-months | The number of participants analyzed includes subjects who were available at that time of analysis | percentage of participants | NUMBER |
| SECONDARY | Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism | At 18-months | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| SECONDARY | Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab | At 45-days | The number of participants analyzed includes subjects who were available at that time of analysis | Percentage of participants | NUMBER |
| POST_HOC | Composite Rate of Ischemic Stroke and Systemic Embolism | 5 Years | Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted. | percentage of participants | NUMBER |
| POST_HOC | Composite Rate of Stroke, Systemic Embolism, or CV/Unexplained Death | 5 Years | Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Amulet | 14.5 | Percentage of participants | ||
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) | WATCHMAN (Control) | 14.7 | Percentage of participants | ||
| Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis) | Amulet | 2.8 | Percentage of participants | ||
| Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis) | WATCHMAN (Control) | 2.8 | Percentage of participants | ||
| Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) | Amulet | 98.9 | Percentage of participants | ||
| Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis) | WATCHMAN (Control) | 96.8 | Percentage of participants | ||
| Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis) | Amulet | 5.6 | Percentage of participants | ||
| Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis) | WATCHMAN (Control) | 7.7 | Percentage of participants | ||
| Rate of Major Bleeding (Superiority Analysis) | Amulet | 11.6 | Percentage of participants | ||
| Rate of Major Bleeding (Superiority Analysis) | WATCHMAN (Control) | 12.3 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amulet | 934 | |
| Overall Study | STARTED | WATCHMAN (Control) | 944 | |
| Overall Study | COMPLETED | Amulet | 610 | |
| Overall Study | COMPLETED | WATCHMAN (Control) | 562 | |
| Overall Study | NOT COMPLETED | Amulet | 324 | |
| Overall Study | NOT COMPLETED | WATCHMAN (Control) | 382 |
Source ClinicalTrials.gov
Adverse events700
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Bloating | Vascular disorders | Amulet | 1 | 934 | |
| other | Abdominal Bloating | Vascular disorders | WATCHMAN (Control) | 0 | 944 | |
| other | Abnormal Lab Value | Investigations | Amulet | 2 | 934 | |
| other | Abnormal Lab Value | Investigations | WATCHMAN (Control) | 0 | 944 | |
| other | Abrasion | Injury, poisoning and procedural complications | Amulet | 0 | 934 | |
| other | Abrasion | Injury, poisoning and procedural complications | WATCHMAN (Control) | 1 | 944 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Amulet | 2 | 934 | |
| other | Acute Kidney Injury | Renal and urinary disorders | WATCHMAN (Control) | 3 | 944 | |
| other | Air Embolus | Injury, poisoning and procedural complications | Amulet | 1 | 934 | |
| other | Air Embolus | Injury, poisoning and procedural complications | WATCHMAN (Control) | 1 | 944 |
1 to 10 of 700Source ClinicalTrials.gov
See all 700 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amulet | 251 | 934 |
| Total, all-cause mortality | WATCHMAN (Control) | 263 | 944 |
| Total, other adverse events | Amulet | 293 | 934 |
| Total, other adverse events | WATCHMAN (Control) | 266 | 944 |
| Total, serious adverse events | Amulet | 542 | 934 |
| Total, serious adverse events | WATCHMAN (Control) | 535 | 944 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amulet vs WATCHMAN (Control): deaths from any cause | Trial comparisons |
| Amulet vs WATCHMAN (Control): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02879448
GET https://conductscience.org/api/trials/v1/NCT02879448/results?page=2