Clinical Trial

LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

Study acronym: AMPIRI

Recruiting

Record status

This record was last updated January 9, 2024 (before its estimated January 15, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2023-09-27.

Status change: Not Yet Recruiting → Recruiting 2024-01-07

Trial Details

NCT Number	NCT06060912
Lead Sponsor	Deutsches Herzzentrum Muenchen Collaborators: Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions	Left Atrial Appendage Occlusion
Enrollment	226 participants
Start Date	2023-12-05
Primary Completion	2026-01-15 (estimated)
Study Completion	2027-10-15 (estimated)
Updated on ClinicalTrials.gov	2024-01-09