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Clinical Trials in Germany / NCT06060912
Recruiting Not applicable

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

NCT06060912 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2023-12-05
Last updated
2024-01-09

Condition(s) studied

Left Atrial Appendage Occlusion

Investigational drug(s) / intervention(s)

Left Atrial Appendage Occlusion

Left Atrial Appendage Occlusion: Left Atrial Appendage Occlusion will be performed according to current international standards by experienced operators under TOE and angiographic guidance. Either a LAmbre occlusion device (group A) or an AMPLATZER Amulet occlusion device (group B) will be implanted depending on treatment allocation.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
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: 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München Munich Bavaria Recruiting

More Deutsches Herzzentrum Muenchen trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06060912 on ClinicalTrials.gov ↗ ← All trials in Germany