Back to resultsLAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs (AMPIRI)
Primary Purpose
Left Atrial Appendage Occlusion
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Left Atrial Appendage Occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Left Atrial Appendage Occlusion focused on measuring Left Atrial Appendage Occlusion, non-pharmacological anticoagulation therapy, stroke prophylaxis
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and able to give consent Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female) Patient not eligible for long-term oral anticoagulation therapy Deemed suitable for percutaneous LAAO Able to comply with the required medication regimen after LAAO device implantation Written informed consent LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial) For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study Exclusion Criteria: Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve) LAA is obliterated or surgically ligated Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen Prior atrial septal defect (ASD) repair or implantation of ASD closure device Active endocarditis or other infection producing bacteremia Significant symptomatic carotid artery disease Participation in a concurrent clinical trial, which may confound the results of this trial Patient cannot adhere to or complete the trial protocol for any reason Or any of the following echocardiographic exclusion criteria: Intracardiac thrombus Intracardiac tumor Existing, clinically relevant circumferential pericardial effusion Significant mitral valve stenosis
Sites / Locations
- Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LAmbre occlusion device
AMPLATZER Amulet occlusion device
Arm Description
Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)
Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)
Outcomes
Primary Outcome Measures
PDL size after 3 months
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
Secondary Outcome Measures
Device Sucess
Defined as device deployed and implanted in correct position.
Procedural Duration
End time (closing of X-Ray) minus start time (access site puncture).
Technical success
Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.
Procedural success
defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization
Device-related complications
All complications which are a result of the presence of the device and require either a surgical or percutaneous intervention or other medical treatment (device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection/pericarditis, endocarditis, device perforation/laceration or device allergy)
Procedure-related complications
Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.
Major bleeding
Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.
Large residual peri-device leak size > 5mm
Large peri device leak size (in mm) >5 mm three months after successful LAAO as assessed with TOE.
Device thrombus
Device thrombus at three months after successful LAAO as assessed with TOE.
All-cause death or cardiovascular death
Cardiovascular Death:
Death due to proximate cardiac cause, e.g. myocardial infarction, cardiac tamponade, worsening heart failure, and endocarditis.
Death caused by non-coronary, non-CNS vascular conditions such as pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
Death from vascular CNS causes from haemorrhagic stroke or from ischaemic stroke.
All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within 1 hour of the onset of symptoms in an apparently healthy subject. If death is not witnessed, the definition applies when the victim was in good health 24 hours before the event.
Death of unknown cause:
Non-cardiovascular death: Death of a primary cause that is clearly related to another condition (e.g. trauma, cancer, suicide).
Composite of ischaemic stroke or systemic embolism
Incidence of ischaemic stroke or systemic embolism, as described below.
All-stroke
Defined as an acute episode of focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, one-sided numbness or sensory loss, dysphasia or aphasia, hemianopia, amaurosis fugax or any other neurological signs or symptoms consistent with stroke. It is caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. A transient ischemic attack (TIA) should be clearly distinguished from ischemic stroke, based on focal neurological symptoms lasting <24 hours and imaging-confirmed absence of acute brain infarction. Therefore, it is mandatory to recommend imaging confirmation as part of the diagnosis. Stroke assessment requires a neuroimaging and neurological examination, preferably by a neurologist.
Systemic embolism
Systemic embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system 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.
Full Information
NCT ID
NCT06060912
First Posted
September 11, 2023
Last Updated
September 27, 2023
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06060912
Brief Title
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Acronym
AMPIRI
Official Title
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
October 15, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.
The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
Detailed Description
AMPIRI is an investigator-initiated, prospective, randomized, one-sided blinded, multi-center, open-label, non-inferiority other clinical investigation. All consecutive patients with non-valvular AF at increased risk for stroke or systemic embolism based on CHA2DS2-VASc score not eligible for long-term oral anticoagulation therapy will qualify for screening. Patients with confirmed eligibility and who have given written informed consent will be randomized in a 1:1 fashion to group A (LAmbre LAAO device) or group B (AMPLATZER Amulet LAAO device). Clinical indication, technique, and timing of LAAO will be at the operator's discretion.
The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Atrial Appendage Occlusion
Keywords
Left Atrial Appendage Occlusion, non-pharmacological anticoagulation therapy, stroke prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AMPIRI is an investigator-initiated, prospective, randomized, one-sided blinded, multicenter, open-label, non-inferiority other clinical investigation.
Masking
Participant
Masking Description
Patients will not know if they were randomized to group A or group B.
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAmbre occlusion device
Arm Type
Experimental
Arm Description
Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)
Arm Title
AMPLATZER Amulet occlusion device
Arm Type
Active Comparator
Arm Description
Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)
Intervention Type
Device
Intervention Name(s)
Left Atrial Appendage Occlusion
Intervention Description
Left Atrial Appendage Occlusion will be performed according to current international standards by experienced operators under TOE and angiographic guidance. Either a LAmbre occlusion device (group A) or an AMPLATZER Amulet occlusion device (group B) will be implanted depending on treatment allocation.
Primary Outcome Measure Information:
Title
PDL size after 3 months
Description
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Device Sucess
Description
Defined as device deployed and implanted in correct position.
Time Frame
at index prozedure
Title
Procedural Duration
Description
End time (closing of X-Ray) minus start time (access site puncture).
Time Frame
at index procedure
Title
Technical success
Description
Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.
Time Frame
during index hospitalization
Title
Procedural success
Description
defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization
Time Frame
at index procedure
Title
Device-related complications
Description
All complications which are a result of the presence of the device and require either a surgical or percutaneous intervention or other medical treatment (device embolization, device erosion, clinically significant device interference with surrounding structure, device thrombus, device fracture, device infection/pericarditis, endocarditis, device perforation/laceration or device allergy)
Time Frame
at three months
Title
Procedure-related complications
Description
Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.
Time Frame
during index hospitalization
Title
Major bleeding
Description
Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.
Time Frame
during index hospitalization
Title
Large residual peri-device leak size > 5mm
Description
Large peri device leak size (in mm) >5 mm three months after successful LAAO as assessed with TOE.
Time Frame
at three months
Title
Device thrombus
Description
Device thrombus at three months after successful LAAO as assessed with TOE.
Time Frame
at three months
Title
All-cause death or cardiovascular death
Description
Cardiovascular Death:
Death due to proximate cardiac cause, e.g. myocardial infarction, cardiac tamponade, worsening heart failure, and endocarditis.
Death caused by non-coronary, non-CNS vascular conditions such as pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
Death from vascular CNS causes from haemorrhagic stroke or from ischaemic stroke.
All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
Sudden or unwitnessed death defined as non-traumatic, unexpected fatal event occurring within 1 hour of the onset of symptoms in an apparently healthy subject. If death is not witnessed, the definition applies when the victim was in good health 24 hours before the event.
Death of unknown cause:
Non-cardiovascular death: Death of a primary cause that is clearly related to another condition (e.g. trauma, cancer, suicide).
Time Frame
during index hospitalization and up to 24 months
Title
Composite of ischaemic stroke or systemic embolism
Description
Incidence of ischaemic stroke or systemic embolism, as described below.
Time Frame
during index hospitalization and up to 24 months
Title
All-stroke
Description
Defined as an acute episode of focal or global neurological deficit with at least one of the following: change in the level of consciousness, hemiplegia, hemiparesis, one-sided numbness or sensory loss, dysphasia or aphasia, hemianopia, amaurosis fugax or any other neurological signs or symptoms consistent with stroke. It is caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. A transient ischemic attack (TIA) should be clearly distinguished from ischemic stroke, based on focal neurological symptoms lasting <24 hours and imaging-confirmed absence of acute brain infarction. Therefore, it is mandatory to recommend imaging confirmation as part of the diagnosis. Stroke assessment requires a neuroimaging and neurological examination, preferably by a neurologist.
Time Frame
during index hospitalization and up to 24 months
Title
Systemic embolism
Description
Systemic embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system 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.
Time Frame
during index hospitalization and up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years and able to give consent
Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)
Patient not eligible for long-term oral anticoagulation therapy
Deemed suitable for percutaneous LAAO
Able to comply with the required medication regimen after LAAO device implantation
Written informed consent
LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)
For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study
Exclusion Criteria:
Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
LAA is obliterated or surgically ligated
Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
Prior atrial septal defect (ASD) repair or implantation of ASD closure device
Active endocarditis or other infection producing bacteremia
Significant symptomatic carotid artery disease
Participation in a concurrent clinical trial, which may confound the results of this trial
Patient cannot adhere to or complete the trial protocol for any reason
Or any of the following echocardiographic exclusion criteria:
Intracardiac thrombus
Intracardiac tumor
Existing, clinically relevant circumferential pericardial effusion
Significant mitral valve stenosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Joner, MD
Phone
+4989-1218-2869
Email
joner@dhm.mhn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Rheude, MD
Phone
+4989-1218-2985
Email
rheude@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Joner, MD
Organizational Affiliation
Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
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