LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

Deutsches Herzzentrum Muenchen226 enrolled

Overview

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.

AMPIRI is an investigator-initiated, prospective, randomized, 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 PDL size 3 months after LAAO, as assessed with TOE in patients with non-valvular AF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

226

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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: 1. Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve) 2. LAA is obliterated or surgically ligated 3. Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen 4. Prior atrial septal defect (ASD) repair or implantation of ASD closure device 5. Active endocarditis or other infection producing bacteremia 6. Significant symptomatic carotid artery disease 7. Participation in a concurrent clinical trial, which may confound the results of this trial 8. Patient cannot adhere to or complete the trial protocol for any reason Or any of the following echocardiographic exclusion criteria: 9. Intracardiac thrombus 10. Intracardiac tumor 11. Existing, clinically relevant circumferential pericardial effusion 12. Significant mitral valve stenosis

Outcomes

Primary Outcomes

PDL size after 3 months

Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.

Time frame: three months

Secondary Outcomes

Device Sucess

Defined as device deployed and implanted in correct position.

Time frame: at index prozedure

Procedural Duration

End time (closing of X-Ray) minus start time (access site puncture).

Time frame: at index procedure

Technical success

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

Procedural success

defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization

Time frame: at index procedure

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)

Time frame: at three months

Procedure-related complications

Pericardial effusion with or without tamponade requiring pericardiocentesis or surgical intervention.

Time frame: during index hospitalization

Major bleeding

Defined as Bleeding Academic Research Consortium (BARC) type ≥ 3.

Time frame: during index hospitalization

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.

Time frame: at three months

Device thrombus

Device thrombus at three months after successful LAAO as assessed with TOE.

Time frame: at three months

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).

Time frame: during index hospitalization and up to 24 months

Composite of ischaemic stroke or systemic embolism

Incidence of ischaemic stroke or systemic embolism, as described below.

Time frame: during index hospitalization and up to 24 months

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.

Time frame: during index hospitalization and up to 24 months

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.

Time frame: during index hospitalization and up to 24 months

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts