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RecruitingNot ApplicableNCT06060912

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial

Sponsor

Deutsches Herzzentrum Muenchen

Enrollment

226 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Left Atrial Appendage Occlusion

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria8

  • 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 Criteria12

  • 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
  • Intracardiac thrombus
  • Intracardiac tumor
  • Existing, clinically relevant circumferential pericardial effusion
  • Significant mitral valve stenosis

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Interventions

DEVICELeft 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.

Locations(1)

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München

Munich, Bavaria, Germany

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NCT06060912