Actively Recruiting
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Led by Deutsches Herzzentrum Muenchen · Updated on 2024-01-09
226
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
D
Deutsches Herzzentrum Muenchen
Lead Sponsor
L
Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to give consent
- Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation or atrial flutter with high stroke risk (CHA2DS2-VASc score ≥ 2 for males or ≥ 3 for females)
- Not eligible for long-term oral anticoagulation therapy
- Suitable for percutaneous left atrial appendage occlusion
- Able to comply with required medication after device implantation
- Provided written informed consent
- Left atrial appendage anatomy suitable for both LAmbre and AMPLATZER Amulet devices as per manufacturer instructions
- For women of childbearing potential, negative pregnancy test and agreement to use reliable birth control during the study
You will not qualify if you...
- Need for long-term oral anticoagulation for conditions other than atrial fibrillation (e.g., pulmonary embolism, mechanical heart valve)
- Left atrial appendage is obliterated or surgically closed
- Allergy or hypersensitivity to device components or required medications
- Prior atrial septal defect repair or closure device implantation
- Active infection causing bacteremia
- Significant symptomatic carotid artery disease
- Participation in another clinical trial that may affect results
- Inability to adhere to or complete the trial protocol
- Echocardiographic exclusions: intracardiac thrombus, intracardiac tumor, significant pericardial effusion, significant mitral valve stenosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
Munich, Bavaria, Germany, 80636
Actively Recruiting
Research Team
M
Michael Joner, MD
CONTACT
T
Tobias Rheude, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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