LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- PDL size after 3 months
Study Overview
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, 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LAmbre occlusion device
Left atrial occlusion will be performed with the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China)
Intervention: Left Atrial Appendage Occlusion (Device)
AMPLATZER Amulet occlusion device
Left atrial occlusion will be performed with AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA)
Intervention: Left Atrial Appendage Occlusion (Device)
Outcomes
Primary Outcomes
PDL size after 3 months
Time Frame: three months
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
Secondary Outcomes
- Composite of ischaemic stroke or systemic embolism(during index hospitalization and up to 24 months)
- Procedural Duration(at index procedure)
- Device-related complications(at three months)
- All-stroke(during index hospitalization and up to 24 months)
- Device Sucess(at index prozedure)
- Procedural success(at index procedure)
- Large residual peri-device leak size > 5mm(at three months)
- Systemic embolism(during index hospitalization and up to 24 months)
- Procedure-related complications(during index hospitalization)
- Device thrombus(at three months)
- Technical success(during index hospitalization)
- Major bleeding(during index hospitalization)
- All-cause death or cardiovascular death(during index hospitalization and up to 24 months)