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LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

NCT06060912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2024-01-09

No results posted yet for this 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.

Conditions

  • Left Atrial Appendage Occlusion

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    collaborator INDUSTRY

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Michael Joner, MD · Klinik für Herz- und Kreilauferkankungen, Deutsches Herzzentrum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2026-01-15
Completion
2027-10-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06060912 on ClinicalTrials.gov