Compares two devices that close the left atrial appendage in people with atrial fibrillation
Compares two heart devices that close the left atrial appendage in atrial fibrillation.
Plain-language title generated from the registry record
Registry title: LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs
Key facts
- Where
- Munich, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06060912, who can take part
Where in Germany
- Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität MünchenMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Deutsches Herzzentrum Muenchen
- Trial code
- NCT06060912
- Record updated
- 9 January 2024
- Original description
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.Read full original descriptionShow less
LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
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.
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: Prior atrial septal defect (ASD) repair or implantation of ASD closure device; Participation in a concurrent clinical trial, which may confound the results of this trial; Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve); Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen; Active endocarditis or other infection producing bacteremia; Significant symptomatic carotid artery disease; LAA is obliterated or surgically ligated; 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.