Last updated: January 7, 2024
Sponsor: Deutsches Herzzentrum Muenchen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stroke
Cerebral Ischemia
Treatment
Left Atrial Appendage Occlusion
Clinical Study ID
NCT06060912
GE IDE No. T00322
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 byCHA2DS2-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 permanufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriatefor both devices in order to be enrolled in the trial)
- For women of childbearing potential, negative pregnancy test and agree to use reliablemethod of birth control during the study
Exclusion
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 componentsof 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 thistrial
- 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
Study Design
Total Participants: 226
Treatment Group(s): 1
Primary Treatment: Left Atrial Appendage Occlusion
Phase:
Study Start date:
December 05, 2023
Estimated Completion Date:
October 15, 2027
Study Description
Connect with a study center
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München
Munich, Bavaria 80636
GermanyActive - Recruiting
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