Status:
RECRUITING
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Left Atrial Appendage Occlusion
Eligibility:
All Genders
18-100 years
Phase:
NA
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 ...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06060912
Start Date
December 5 2023
End Date
October 15 2027
Last Update
January 9 2024
Active Locations (1)
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1
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
Munich, Bavaria, Germany, 80636