LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

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

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 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:

  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 componentsof 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 thistrial
  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

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

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 for stroke or systemic embolism based on CHA2DS2-VASc score not eligible for long-term oral anticoagulation therapy will qualify for screening. Patients with confirmed eligibility and who have given written informed consent will be randomized in a 1:1 fashion to group A (LAmbre LAAO device) or group B (AMPLATZER Amulet LAAO device). Clinical indication, technique, and timing of LAAO will be at the operator's discretion.

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 PDL size 3 months after LAAO, as assessed with TOE in patients with non-valvular AF.

Connect with a study center

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

    Munich, Bavaria 80636
    Germany

    Active - Recruiting

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