Trial Outcomes & Findings for AMPLATZER™ Cardiac Plug Observational Post-Approval Study (NCT NCT02954237)
NCT ID: NCT02954237
Last Updated: 2022-06-24
Results Overview
The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
Recruitment status
COMPLETED
Target enrollment
91 participants
Primary outcome timeframe
Within 7 days of the procedure
Results posted on
2022-06-24
Participant Flow
A total of 94 subjects were consented, and 91 were enrolled in the study. The first and last Amplatzer Cardiac Plug implants as part of the study occured on 14-Nov-2016 and 12-Mar-2019, respectively. The final 24-month follow-up visit occurred on 29-Jan-2021.
Participant milestones
| Measure |
AMPLATZER™ Cardiac Plug
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
|
Overall Study
STARTED
|
91
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
AMPLATZER™ Cardiac Plug
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
|
Overall Study
Missed visit
|
16
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AMPLATZER™ Cardiac Plug
n=91 Participants
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
|
|---|---|
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Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 8.5 • n=91 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=91 Participants
|
|
Region of Enrollment
China
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91 Participants
n=91 Participants
|
|
HAS-BLED Score
|
3.5 scores on a scale
STANDARD_DEVIATION 0.7 • n=91 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of the procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The primary short-term safety endpoint was the composite of death, stroke (ischemic or haemorrhagic), systemic embolism and procedure or device-related complications requiring major cardiovascular or endovascular intervention.
Outcome measures
| Measure |
AMPLATZER™ Cardiac Plug
n=91 Participants
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
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Short-Term Safety Endpoint: Composite Rate of Death, Stroke, Systemic Embolism, and Procedure or Device-related Complications Requiring Intervention
|
1.1 percentage of participants
Interval 0.03 to 5.97
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PRIMARY outcome
Timeframe: Within 2 years of the procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The primary long-term safety endpoint was the composite of of device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection (endocarditis and pericarditis), device perforation, device laceration, or device allergy.
Outcome measures
| Measure |
AMPLATZER™ Cardiac Plug
n=91 Participants
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
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Long-Term Safety Endpoint: Composite Rate of Device Embolization/Device Erosion/Device Interference With Surrounding Structure/Device Thrombus/Device Fracture/Device Infection/Device Perforation/Device Laceration/Device Allergy
|
2.2 percentage of participants
Interval 0.57 to 8.69
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PRIMARY outcome
Timeframe: Within 2 years of the procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The primary long-term effectiveness endpoint was the composite rate of ischemic stroke or systemic embolism.
Outcome measures
| Measure |
AMPLATZER™ Cardiac Plug
n=91 Participants
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
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Long-Term Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism
|
1.1 percentage of participants
Interval 0.16 to 7.54
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Adverse Events
AMPLATZER™ Cardiac Plug
Serious events: 28 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
AMPLATZER™ Cardiac Plug
n=91 participants at risk
Subjects who were implanted with AMPLATZER™ Cardiac Plug will be included in this arm.
AMPLATZER™ Cardiac Plug: The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
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|---|---|
|
Cardiac disorders
Angina pectoris
|
2.2%
2/91 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
1.1%
1/91 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.1%
1/91 • 2 years
|
|
Gastrointestinal disorders
Cholelithiasis
|
1.1%
1/91 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
2.2%
2/91 • 2 years
|
|
Cardiac disorders
Congestive Heart Failure
|
3.3%
3/91 • 2 years
|
|
General disorders
Facial Paresis
|
1.1%
1/91 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/91 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.1%
1/91 • 2 years
|
|
Cardiac disorders
Heart Failure
|
3.3%
3/91 • 2 years
|
|
Blood and lymphatic system disorders
Hemangioma
|
1.1%
1/91 • 2 years
|
|
Blood and lymphatic system disorders
Intracerebral Haemorrhage
|
1.1%
1/91 • 2 years
|
|
Cardiac disorders
Pericardial Effusion
|
1.1%
1/91 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
3/91 • 2 years
|
|
Reproductive system and breast disorders
Post-Menopausal Bleeding
|
1.1%
1/91 • 2 years
|
|
Nervous system disorders
Seizure/Convulsions/Epilepsy
|
1.1%
1/91 • 2 years
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
2.2%
2/91 • 2 years
|
|
Nervous system disorders
Stroke
|
1.1%
1/91 • 2 years
|
|
Vascular disorders
Subdural Haemorrhage
|
1.1%
1/91 • 2 years
|
|
Injury, poisoning and procedural complications
Thrombus on Device
|
1.1%
1/91 • 2 years
|
|
Nervous system disorders
Unmasking Old Stroke Symptoms
|
1.1%
1/91 • 2 years
|
|
Blood and lymphatic system disorders
VASC Hematoma
|
1.1%
1/91 • 2 years
|
|
Nervous system disorders
Vertigo
|
1.1%
1/91 • 2 years
|
|
General disorders
Other - Anaphylactic Shock
|
1.1%
1/91 • 2 years
|
|
Cardiac disorders
Other - Arrhythmia
|
1.1%
1/91 • 2 years
|
|
Blood and lymphatic system disorders
Other - Pancytopenia
|
1.1%
1/91 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER