Trial Outcomes & Findings for AMPLATZER™ LAA Occluder Post Approval Study (PAS) (NCT NCT02964208)
NCT ID: NCT02964208
Last Updated: 2024-03-29
Results Overview
The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment
Recruitment status
COMPLETED
Target enrollment
520 participants
Primary outcome timeframe
Implant through 24 months
Results posted on
2024-03-29
Participant Flow
A total of 520 patients were enrolled and underwent Amplatzer LAA Occluder implant attempt at 22 investigational sites between December 8, 2016 and July 2, 2020.
Participant milestones
| Measure |
LAA Occluder PAS
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Overall Study
STARTED
|
520
|
|
Overall Study
COMPLETED
|
396
|
|
Overall Study
NOT COMPLETED
|
124
|
Reasons for withdrawal
| Measure |
LAA Occluder PAS
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Overall Study
Death
|
103
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Unsuccessful Procedure
|
5
|
|
Overall Study
Device Explant
|
1
|
|
Overall Study
Anatomical Heart Structure of the Patient; LAA Occluder Was Not Implanted; Heart Transplant
|
3
|
Baseline Characteristics
AMPLATZER™ LAA Occluder Post Approval Study (PAS)
Baseline characteristics by cohort
| Measure |
LAA Occluder PAS
n=520 Participants
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Age, Continuous
|
75.90 Years
STANDARD_DEVIATION 8.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
335 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
248 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
224 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
187 Participants
n=5 Participants
|
|
Medical History
History of Major Bleeding
|
392 Participants
n=5 Participants
|
|
Medical History
HAS-BLED score
|
520 Participants
n=5 Participants
|
|
Medical History
History of TIA
|
65 Participants
n=5 Participants
|
|
Medical History
History of Stroke
|
160 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implant through 24 monthsPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment
Outcome measures
| Measure |
LAA Occluder PAS
n=513 Participants
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Primary Effectiveness Endpoint 1: Composite Rate of Stroke (Including Ischemic or Hemorrhagic), Systemic Embolism and Cardiovascular or Unexplained Death
|
14.28 percentage of participants
|
PRIMARY outcome
Timeframe: Implant through 24 monthsPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
Outcome measures
| Measure |
LAA Occluder PAS
n=513 Participants
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Primary Effectiveness Endpoint 2: Composite Rate of Ischemic Stroke or Systemic Embolism
|
4.41 percentage of participants
|
PRIMARY outcome
Timeframe: Implant through 7 daysPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair
Outcome measures
| Measure |
LAA Occluder PAS
n=520 Participants
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Primary Safety Endpoint: Number of Subjects With All Cause Death, Ischemic Stroke, Systemic Embolism, or Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Repair
|
3 Participants
|
SECONDARY outcome
Timeframe: Implant through 24 monthsPopulation: The number of participants analyzed includes subjects for whom data were available at that time of analysis.
The secondary endpoint comparing the observed rate of ischemic stroke at 24 months with the congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category (CHA2DS2-VASc) score predicted rate for the implant population. The following calculation was used to calculate the Relative Risk Decrease: (Predicted Rate minus Observed Rate) divided by Predicted Rate = Relative Risk Decrease.
Outcome measures
| Measure |
LAA Occluder PAS
n=520 Participants
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Comparison of the Relative Risk Decrease Of Observed Rate of Ischemic Stroke at 24 Months With the CHA2DS2-VASc Predicted Rate for the Implant Population
|
-70 percent change in the rate
|
Adverse Events
LAA Occluder PAS
Serious events: 201 serious events
Other events: 3 other events
Deaths: 103 deaths
Serious adverse events
| Measure |
LAA Occluder PAS
n=520 participants at risk
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Blood and lymphatic system disorders
Anemias
|
3.3%
17/520 • 24 months
|
|
Blood and lymphatic system disorders
Iron-Deficiency Anemia
|
0.19%
1/520 • 24 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.58%
3/520 • 24 months
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
6/520 • 24 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.38%
2/520 • 24 months
|
|
Cardiac disorders
Congestive Heart Failure
|
1.3%
7/520 • 24 months
|
|
Cardiac disorders
Decompensated Heart Failure
|
0.38%
2/520 • 24 months
|
|
Cardiac disorders
Heart Failure
|
1.5%
8/520 • 24 months
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
0.38%
2/520 • 24 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.58%
3/520 • 24 months
|
|
Cardiac disorders
Pericardial Effusion
|
0.77%
4/520 • 24 months
|
|
Cardiac disorders
Pericardial Tamponade
|
2.1%
11/520 • 24 months
|
|
Cardiac disorders
Pericarditis
|
0.77%
4/520 • 24 months
|
|
Cardiac disorders
Persistent Atrial Fibrillation
|
0.19%
1/520 • 24 months
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.19%
1/520 • 24 months
|
|
Cardiac disorders
Thrombus
|
0.38%
2/520 • 24 months
|
|
Eye disorders
Retinal Hemorrhage
|
0.19%
1/520 • 24 months
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.19%
1/520 • 24 months
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/520 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
6.7%
35/520 • 24 months
|
|
General disorders
Ascites
|
0.19%
1/520 • 24 months
|
|
General disorders
Change in Gait
|
0.19%
1/520 • 24 months
|
|
General disorders
Dizziness
|
0.19%
1/520 • 24 months
|
|
General disorders
Failure to Thrive
|
0.19%
1/520 • 24 months
|
|
General disorders
Multiple Organ Failure
|
0.96%
5/520 • 24 months
|
|
General disorders
Other
|
1.9%
10/520 • 24 months
|
|
Hepatobiliary disorders
Hepatic and Biliary Disorders
|
0.19%
1/520 • 24 months
|
|
Hepatobiliary disorders
Pancreatic Cancer
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Acute Bacterial Endocarditis (ABE)
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Acute Peritonitis
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
|
0.58%
3/520 • 24 months
|
|
Infections and infestations
Chlamydial Pneumonia
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Pneumonia
|
1.2%
6/520 • 24 months
|
|
Infections and infestations
Pneumonia Caused By Gram-Negative Bacilli
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Sepsis
|
1.7%
9/520 • 24 months
|
|
Infections and infestations
Septicemia
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Urinary Tract Infections
|
0.19%
1/520 • 24 months
|
|
Infections and infestations
Viral Syndrome
|
0.19%
1/520 • 24 months
|
|
Injury, poisoning and procedural complications
Closed Head Injury
|
0.19%
1/520 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/520 • 24 months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.38%
2/520 • 24 months
|
|
Injury, poisoning and procedural complications
Trauma
|
0.38%
2/520 • 24 months
|
|
Investigations
Abnormal Lab Value
|
0.19%
1/520 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.2%
6/520 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.38%
2/520 • 24 months
|
|
Nervous system disorders
Acute Subdural Hematoma
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Delirium
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Encephalopathy
|
0.58%
3/520 • 24 months
|
|
Nervous system disorders
Incidental Finding of Stroke
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Intracerebral Haemorrhage
|
1.7%
9/520 • 24 months
|
|
Nervous system disorders
Ischemic Stroke
|
3.3%
17/520 • 24 months
|
|
Nervous system disorders
Myoclonus
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Paresthesia/Paraesthesia
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
0.77%
4/520 • 24 months
|
|
Nervous system disorders
Stroke
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.77%
4/520 • 24 months
|
|
Nervous system disorders
Vertigo
|
0.19%
1/520 • 24 months
|
|
Product Issues
Device Migration
|
0.19%
1/520 • 24 months
|
|
Product Issues
Thrombus on Device
|
0.58%
3/520 • 24 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.19%
1/520 • 24 months
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.19%
1/520 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
0.19%
1/520 • 24 months
|
|
Renal and urinary disorders
Renal Failure
|
0.96%
5/520 • 24 months
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.19%
1/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.38%
2/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.38%
2/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.19%
1/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.19%
1/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.58%
3/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.38%
2/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.3%
7/520 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.5%
8/520 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hemarthrosis
|
0.19%
1/520 • 24 months
|
|
Skin and subcutaneous tissue disorders
Seroma
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Bleeding
|
0.58%
3/520 • 24 months
|
|
Vascular disorders
Carotid Aneurysm
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Deep Vein/Venous Thrombosis
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Hematoma
|
1.3%
7/520 • 24 months
|
|
Vascular disorders
Hemorrhage
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
Perforation of Vessel
|
0.38%
2/520 • 24 months
|
|
Vascular disorders
Peripheral Arterial Occlusion
|
0.38%
2/520 • 24 months
|
|
Vascular disorders
Syncope
|
0.19%
1/520 • 24 months
|
|
Vascular disorders
VASC Bleeding
|
0.38%
2/520 • 24 months
|
|
Vascular disorders
VASC Pseudoaneurysm
|
0.58%
3/520 • 24 months
|
Other adverse events
| Measure |
LAA Occluder PAS
n=520 participants at risk
Subjects who were treated with AMPLATZER LAA Occluders will be included.
|
|---|---|
|
Product Issues
Thrombus on Device
|
0.19%
1/520 • 24 months
|
|
Nervous system disorders
Transient Ischemic Attack (TIA)
|
0.19%
1/520 • 24 months
|
|
Cardiac disorders
Unstable Angina
|
0.19%
1/520 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place